Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients is required; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced oophorectomy with last menses > 1 year ago, had chemotherapy-induced menopause with > 1 year interval since last menses, or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXPostmenopausal or evidence of non-childbearing status for women of childbearing potential a negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH )and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXPatients must not be pregnant or nursing\r\n* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potentialXx_NEWLINE_xXPostmenopausal, verified by: \r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standardsXx_NEWLINE_xXPre/peri- and postmenopausal women and all men are eligible for this trial; postmenopausal is defined as:\r\n* Age >= 55 years and one year or more of amenorrhea\r\n* Age < 55 years and one year or more of amenorrhea, with estradiol < 20 pg/ml\r\n* Age < 55 with prior hysterectomy but intact ovaries, with estradiol < 20 pg/ml\r\n* Prior bilateral oophorectomy\r\nNOTE: Women who do not fit the criteria for being postmenopausal as above are deemed pre-or peri-menopausal; pre/perimenopausal women and all men can enroll provided they agree to receive concomitant luteinizing hormone-releasing hormone (LHRH) agonist; pre/perimenopausal women must have commenced treatment with LHRH agonist at least 4 weeks prior to randomization; if patients have received alternative LHRH agonist prior to study entry, they must switch to goserelin for the duration of the trialXx_NEWLINE_xXWomen who are not postmenopausal or have not undergone a hysterectomy must have documented negative pregnancy test within 28 days prior to randomization\r\n* Postmenopausal is defined as one or more of the following: \r\n** Age >= 60 years (yrs)\r\n** Age < 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment\r\n** Follicle-stimulating hormone (FSH) and plasma estradiol levels in the post menopausal range for women under 60\r\n** Radiation-induced oophorectomy with last menses > 1 year ago\r\n** Bilateral oophorectomy\r\n* Female patients of childbearing potential who are sexually active must agree, with their partners, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 1 month after the last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse; male patients must agree, with their partners who are sexually active and of childbearing potential, to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourseXx_NEWLINE_xXWomen of child-bearing potential and men must agree to use highly effective contraception for appropriate methods of contraception) prior to study entry, for the duration of study participation, and for at least 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use two highly effective forms of contraception in combination prior to the study, for the duration of study participation, and for at least 5 months (150 days) after completion of atezolizumab and/or olaparib administration; women of child-bearing potential: negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1\r\nPostmenopausal or evidence of non-childbearing status for women of childbearing potential; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen who are not postmenopausal or have not undergone hysterectomy must have a documented negative pregnancy test within 14 days prior to study registration\r\n* Note: Postmenopausal is defined as one or more of the following:\r\n** Age >= 60 years\r\n** Age < 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n** Bilateral oophorectomyXx_NEWLINE_xXWomen of childbearing potential must have a negative urine or serum pregnancy test within 28 days of initial dose of olaparib and temozolomide AND must agree to the use of two highly effective forms of contraception throughout their participation in the study and for at least 3 months after the last dose of olaparib and temozolomide, OR confirmed prior to treatment on day 1 to be postmenopausal or surgically sterile; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXSubjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L)Xx_NEWLINE_xXSubjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRTXx_NEWLINE_xXWomen of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least 23 weeks following the last dose of study treatment (5 half-lives of study drug plus 30 days duration of ovulatory cycle).\r\n* WOCBP are defined as those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopausal is defined as:\r\n** Amenorrhea >= 12 consecutive months without another cause, or\r\n** For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL.Xx_NEWLINE_xXPost-menopausal or evidence of non-childbearing status for women of childbearing potential; for women who are not post-menopausal, a negative urine or serum pregnancy test is required within 28 days of study treatment and confirmed prior to treatment on day 1; post-menopausal is defined as one of the following:\r\n* > 60 years old\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXFemales should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as:\r\n** Aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n** Estradiol, follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels in post-menopausal range while receiving gonadotrophin releasing hormone (LHRH) analogues for medical castration in patients with breast cancer\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXWomen of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause, defined as no menses for at least 1 year AND either age ?65 years or follicle-stimulating hormone levels in the menopausal range.Xx_NEWLINE_xXPostmenopausal status or receiving ovarian ablation with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin or leuprolide; postmenopausal status is defined by any one of the following criteria:\r\n* Prior bilateral oophorectomy\r\n* Prior ovarian radiation for the purpose of ablation\r\n* Age >= 60 years\r\n* Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, or ovarian suppression) and follicle stimulating hormones (FSH), luteinizing (LH), and estradiol in the postmenopausal range per local normalXx_NEWLINE_xXCohort B Safety Run-In (Ribociclib + PDR001 + Fulvestrant): Women must be postmenopausal as defined as:\r\n* Age > 60 years or\r\n* Age > 45 with intact uterus and amenorrhea for >= 12 consecutive months or follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility OR\r\n* Premenopausal women who have been on a GnRH agonist for at least 6 weeks prior to study entry; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment OR\r\n* Status post bilateral oophorectomy, after adequate healing post-surgeryXx_NEWLINE_xXExpansion Cohort B (Ribociclib + PDR001 + Fulvestrant): Women must be postmenopausal as defined as:\r\n* Age > 60 years or\r\n* Age > 45 with intact uterus and amenorrhea for >= 12 consecutive months or follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility OR\r\n* Premenopausal women who have been on a GnRH agonist for at least 6 weeks prior to study entry; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment OR\r\n* Status post bilateral oophorectomy, after adequate healing post-surgeryXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 7 days prior to registration; NOTE: women are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXWomen of childbearing potential must have a negative serum pregnancy test; and additionally agree to simultaneously use at least 2 methods of effective contraception or abstain from heterosexual intercourse from the time of signing consent, and until 4 months after patient’s last dose of protocol-indicated treatment; periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception; women of child bearing potential (WOCBP) are defined as those not surgically sterile or not post-menopausal; if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for at least 1 year in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential; postmenopausal status in females under 55 years of age should be confirmed with a serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal womenXx_NEWLINE_xXClinically confirmed as postmenopausal.Xx_NEWLINE_xXPostmenopausal women as defined as:\r\n* Age > 60 years or\r\n* Age >= 45 with intact uterus and amenorrhea for >= 12 consecutive months or follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility or\r\n* Premenopausal women who have been on a gonadotrophin releasing hormone (GnRH) agonist for at least 6 weeks prior to study entry; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment or\r\n* Status post bilateral oophorectomy, after adequate healing post-surgeryXx_NEWLINE_xXMenopausal status\r\n* Both pre- and post-menopausal patients are permitted into the study; for patients in Cohort C who are pre-menopausal, therapy with a gonadotropin-releasing hormone analogue (leuprolide acetate preferred) must be commenced at least 4 weeks before commencing trial therapy; post-menopausal status is defined either by \r\n** Prior bilateral oophorectomy\r\n** Age greater than 60\r\n** Age less than 60 years with an intact uterus and amenorrhoeic for at last 12 months. \r\n** For patients aged less than 60 years with amenorrhea for less than 12 months (including patients with prior hysterectomy, those who have received hormone replacement therapy, or those rendered amenorrhoeic by chemotherapy), follicle-stimulating hormonal (FSH) levels in the post-menopausal range define the post-menopausal stateXx_NEWLINE_xXPost-menopausal defined as the absence of menses for at least one year (serum FSH ?20IU/L can also be measured according to local practice), ORXx_NEWLINE_xXPostmenopausal status, defined as no menstrual cycle for 12 months or surgical removal of ovariesXx_NEWLINE_xXFor all Parts except Part F and H: Participants must have either post-menopausal status or pre-menopausal status if continuing or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist such as goserelin.Xx_NEWLINE_xXWomen of child-bearing potential (WOCBP) comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below)\r\n* Post-menopause is defined as:\r\n** Women who have had amenorrhea for >= 12 consecutive months (without another cause) and who have a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL\r\n** Women who have irregular menstrual periods and a documented serum FSH level > 35 mIU/mL\r\n** Women who are taking hormone replacement therapy (HRT)Xx_NEWLINE_xXWomen of childbearing potential enrolling on study must have a negative serum pregnancy test prior to registration.\r\n* Childbearing potential is defined as women who are not postmenopausal (defined as amenorrheic for >= 12 months following cessation of any exogenous hormonal treatments; luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50; radiation-induced oophorectomy with last menses > 12 months prior; or chemotherapy-induced menopause with last menses > 12 months prior) or surgically sterile (bilateral oophorectomy or hysterectomy).Xx_NEWLINE_xXMale patients: willing to use adequate contraception (barrier or abstinence) while on treatment with study drug and for 3 months after finishing treatment\r\n* Female patients: willing to use adequate contraception (barrier or abstinence) at least 2 weeks before receiving any study medication, while on treatment with study drug, and for 3 months after finishing treatment\r\n* Female patients: must not be pregnant or breast-feeding; women of child-bearing potential must have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: \r\n** Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n** Women under 50 years are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n** Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.Xx_NEWLINE_xXPost-menopausal (>= 60 years of age or with follicle stimulating hormone [FSH] > 30 IU/L if age 50-59)Xx_NEWLINE_xXA woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).Xx_NEWLINE_xXOnly females are eligible. Menopausal status: i. Postmenopausal defined by:Xx_NEWLINE_xXAge <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and follicle-stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]). Or ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH during the study.Xx_NEWLINE_xXWomen of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; “women of reproductive potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXFemale patients: Must not be pregnant or breast-feeding; women of child-bearing potential must have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n* Women under 50 years are considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXWomen of childbearing potential enrolling on study must have a negative serum pregnancy test prior to registration\r\n* Childbearing potential is defined as women who are not postmenopausal (defined as amenorrheic for >= 12 months following cessation of any exogenous hormonal treatments; luteinizing hormone [LH] and follicle stimulating hormone [FSH] levels in the postmenopausal range for women under 50; radiation-induced oophorectomy with last menses > 12 months prior; or chemotherapy-induced menopause with last menses > 12 months prior) or surgically sterile (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen of child-bearing potential and men must agree to use enhanced methods of contraception; all women are considered to be of childbearing potential unless they fulfill one of the following criteria at screening:\r\n* Post-menopausal defined as age >= 50 and amenorrheic for at least 12 months OR\r\n* Women age < 50 if they have been amenorrheic for at least 12 months and have a serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) level in the postmenopausal range (per institutional standards)\r\n* If women have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, or bilateral tubal ligation, they are considered post-menopausalXx_NEWLINE_xXPre- or post-menopausal women are allowed; if pre- or peri-menopausal, concurrent ovarian suppression for pre- or peri-menopausal women is requiredXx_NEWLINE_xXPatients who are pregnant or nursing; women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a screening negative serum or urine pregnancy test within 14 days of registration; a second pregnancy test must be done within 24 hours prior to the start of the first cycle of study treatment; women must not be breastfeeding\r\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40mIU/mLXx_NEWLINE_xXpostmenopausal (defined as at least 1 year without menses) prior to screening orXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXPost-menopausal defined as age more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.Xx_NEWLINE_xXWomen under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more, following cessation of exogenous hormonal treatments, and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the laboratory.Xx_NEWLINE_xXOnly postmenopausal women and some premenopausal women (as outlined below) will be eligible; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\r\n* Women will be considered postmenopausal if one of the following is met:\r\n** Prior bilateral oophorectomy\r\n** 60 years of age or older\r\n** Age less than 60 years; amenorrheic for 12 or more months; and follicle stimulating hormone (FSH) and plasma estradiol in the postmenopausal range\r\n* Premenopausal women without childbearing potential are eligible to participate if one of the following criteria is met:\r\n** Prior hysterectomy\r\n** Prior fallopian tubal ligation (cut, tied, or sealed)\r\n** Prior placement of permanent intratubal contraceptive devices (e.g. Essure)Xx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXA female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 milli-International units per milliliter and estradiol < 40 picograms per milliliter (< 140 picomole per liter) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods defined in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 7 months after the last dose of study medication; Negative serum pregnancy test <= 7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.Xx_NEWLINE_xXWomen of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause or\r\n* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mLXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to receiving first dose of protocol-indicated treatment.\r\n* WOCBP is defined as any female who has experienced menarche who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal.\r\n* Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 years of age in the absence of other biological or physiological causes.\r\n* If menopausal status is considered for the purpose of evaluating childbearing potential, women < 62 years of age must have a documented serum follicle stimulating hormone (FSH) level within laboratory reference range for postmenopausal women, in order to be considered postmenopausal and not of childbearing potential.Xx_NEWLINE_xXFemale patients of childbearing potential must agree to use at least two methods of acceptable contraception with a failure rate of < 1% per year from 15 days prior to first trial treatment administration until at least 5 months after study participant’s final dose of study drugs.\r\n* Note: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women.Xx_NEWLINE_xXPregnant women are excluded from this study because olaparib has the potential for teratogenic or abortifacient effects. Women must either be post-menopausal or must have a negative pregnancy test (urine or serum) =< 28 days prior to enrollment and confirmed on day 1 of cycle 1 of study therapy\r\nPostmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1-year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXEvidence of post-menopausal status OR negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply: \r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy, or hysterectomy)\r\n* Women ? 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).Xx_NEWLINE_xXFemale subjects must be either:\r\n* Postmenopausal; defined as age > 55 years with no menses for 12 or more months without an alternative medical cause OR\r\n* Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXINCLUSION - ENROLLMENT: Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:\r\n* No spontaneous menses > 1 year, or\r\n* Bilateral surgical oophorectomy, or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standardsXx_NEWLINE_xXFemale subjects must be postmenopausal or there must be evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments.\r\n* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50.\r\n* Radiation-induced oophorectomy with last menses > 1 year ago.\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses.\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy).Xx_NEWLINE_xXNegative pregnancy test done =< 7 days (or per institutional policy) prior to treatment, for women of childbearing potential only. Female must use highly effective contraceptive measures, and must have a negative pregnancy test or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n* Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).Xx_NEWLINE_xXWomen >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).Xx_NEWLINE_xXPost-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatmentsXx_NEWLINE_xXWomen under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institutionXx_NEWLINE_xXFor female subjects of childbearing potential, willingness to use an effective method of contraception from the start of the screening period until ?3 months after the last dose of cirmtuzumab and ?1 month after the last dose of ibrutinib, whichever is later. Note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone [FSH] levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin [beta HCG]); or is menopausal (age ?50 years with amenorrhea for ?6 months).Xx_NEWLINE_xXWomen will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following age-specific requirements must also apply: \r\n* Women < 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) must also be in the post-menopausal range (as per the institution). \r\n* Women >= 50 years old: they would be consider post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses > 1\r\nyear ago, or have had chemotherapy-induced menopause with > 1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomyXx_NEWLINE_xXAge > 55 years with no menses for 12 or more months without an alternative medical cause.Xx_NEWLINE_xXAge ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; orXx_NEWLINE_xXWomen 18 years of age or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.Xx_NEWLINE_xXWomen of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; “women of reproductive potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXPostmenopausal female patients with metastatic histologically or cytologically confirmed invasive breast cancer; pre or perimenopausal women allowed with the addition of goserelin; postmenopausal status will be defined as following:\r\n* Age >= 60 years\r\n* Age < 60 years and 12 months of amenorrhea plus follicle stimulating hormone and plasma estradiol levels within postmenopausal range by local laboratory assessment in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone (GnRH) agonist or antagonist\r\n* Prior bilateral oophorectomyXx_NEWLINE_xXWomen of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; “women of reproductive potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXFemales of childbearing potential and their male partners are advised to practice a highly effective method of contraception during treatment with rucaparib and for 1 month following the last dose for females and 4 months following the last dose for males; a woman is considered to be of childbearing potential unless one of the following applies:\r\n* Is considered to be permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy\r\n* Is postmenopausal, defined as no menses for 12 months without an alternative medical cause; a high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state\r\n* Highly effective contraception is considered to be a method with a < 1% per year failure rate; recommendations for highly effective contraception while taking rucaparib include:\r\n** Ongoing use of injectable or implantable progesterone\r\n** Placement of an intrauterine device or intrauterine system\r\n** Bilateral tubal occlusion\r\n** Complete (as opposed to periodic) abstinence\r\n** Male sterilization, with appropriate post-vasectomy documentation of absence of sperm in ejaculateXx_NEWLINE_xXWomen are eligible to participate if: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/mL and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.Xx_NEWLINE_xXPost-menopausal or undergoing ovarian suppressionXx_NEWLINE_xXMale and female patients of childbearing potential and at risk for pregnancy must agree to use two highly effective methods of contraception throughout the study and for at least 90 days after the last dose of assigned treatment. Female patients who are not of childbearing potential (permanently sterilized or postmenopausal; i.e., meet at least one of the following criteria):\r\n* Have undergone a documented hysterectomy and/or bilateral oophorectomy; or\r\n* Have medically confirmed ovarian failure; or\r\n* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal womenXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrhea for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced oophorectomy with last menses > 1 year ago, had chemotherapy-induced menopause with > 1 year interval since last menses, or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days prior to receiving first dose of protocol-indicated treatment; and additionally agree to use at least 2 methods of acceptable contraception or abstain from heterosexual intercourse from the time of signing consent, and until 2 months after patient’s last dose of protocol-indicated treatment; WOCBP of childbearing potential are defined as those not surgically sterile or not post-menopausal (i.e. if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential); postmenopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal womenXx_NEWLINE_xXFemale subjects must either be of non-reproductive potential (i.e., post-menopausal as described below) OR history of surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, or had chemotherapy-induced menopause with last menses > 1 year agoXx_NEWLINE_xXWOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal; post menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL or\r\n* Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL or NOTE: FSH level testing is not required for women >= 62 years old with amenorrhea of >= 1 year\r\n* Women on hormone replacement therapy (HRT)Xx_NEWLINE_xXPatients who are pregnant or nursing; women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; WOCBP must have a negative serum pregnancy test within 7 days of study enrollment, prior to dosing nivolumab, then every 6 weeks; after discontinuation from nivolumab these should be repeated at approximately 30 days and approximately 70 days; women must not be breastfeeding\r\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\r\n* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy and/or bilateral oophorectomy) or who is not postmenopausal; menopause is defiled clinically as 12 month amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mlU/mLXx_NEWLINE_xXFemale patients of no childbearing potential must be post-menopausal; post-menopausal female subjects should be defined prior to protocol enrollment by any of the following:\r\n* Subjects at least 60 years of age; OR\r\n* Subjects under 60 years of age and naturally (spontaneous, no alternative pathologic or physiological cause) amenorrhea for at least 12 months; OR\r\n* Medical ovarian failure confirmed by follicle-stimulating hormone (FSH) and estradiol levels in the post menopausal range per local institutional normal range; OR\r\n* Prior bilateral oophorectomy; OR\r\n* Prior radiation castration with amenorrhea for at least 6 months; OR\r\n* Treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (such as goserelin acetate or leuprolide acetate) is permitted for induction of ovarian suppression as long as it has been initiated at least 28 days prior to study enrollmentXx_NEWLINE_xXFemale subjects will be considered of non-reproductive potential if they are either:\r\n* Postmenopausal (defined as at least 24 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR\r\n* Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; OR\r\n* Has a congenital or acquired condition that prevents childbearingXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow upXx_NEWLINE_xXEvidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal subjects; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)Xx_NEWLINE_xXPostmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 7 days of study treatment. Postmenopausal is defined as: amenorrheic for 1 year or more following cessation of exogenous hormonal treatments; luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50; radiation-induced oophorectomy with last menses > 1 year ago; chemotherapy-induced menopause with > 1 year interval since last menses; OR surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXFor women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mLXx_NEWLINE_xXPost-menopausal (if female) defined as: 1) prior bilateral oophorectomy, 2) age 60 or over, or 3) < 60 years and amenorrheic for at least 12 months with follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range per institutional parameters); use of luteinizing hormone-releasing hormone (LHRH) agonists to induce chemical ovarian ablation will not be allowed for this studyXx_NEWLINE_xXNegative serum pregnancy test for females of child bearing potential; females are considered to not be of child bearing potential if they are either:\r\n* Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); \r\n* Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening;\r\n* Has a congenital or acquired condition that prevents childbearingXx_NEWLINE_xXPositive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.Xx_NEWLINE_xXPatients can be premenopausal or postmenopausalXx_NEWLINE_xXWomen of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the administration of the investigational product; female patients who are not of childbearing potential as defined below, are eligible to be included (ie, meet at least one of the following criteria):\r\n* Have undergone a documented hysterectomy and/or bilateral oophorectomy\r\n* Have medically confirmed ovarian failure; or\r\n* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal womenXx_NEWLINE_xXFemale subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec; (note: women not of childbearing potential are defined as: any female who is post-menopausal [age > 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of \postmenopausal range\ for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)Xx_NEWLINE_xXWomen of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to study registration and/or within 72 hours of first dose of study drugs; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; female subjects will be considered of childbearing potential unless they are either:\r\n* Postmenopausal--defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; OR\r\n* Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR\r\n* Have a congenital or acquired condition that prevents childbearingXx_NEWLINE_xXMale and female subjects of childbearing potential who are unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec and 4 months after the last dose of pembrolizumab; (Note: women not of childbearing potential are defined as: any female who is post-menopausal [age >= 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of \postmenopausal range\ for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)Xx_NEWLINE_xXAge > 55 years with no menses for 12 or more months without an alternative medical cause.Xx_NEWLINE_xXAge ? 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L; orXx_NEWLINE_xXThe following age-specific requirements must also apply:\r\nWomen < 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments; the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) must also be in the post-menopausal range (as per the institution); women >= 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses > 1 year ago, or have had chemotherapy-induced menopause with > 1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomyXx_NEWLINE_xXWomen of childbearing potential must have a negative B-Human chorionic gonadotropin (HCG) documented within 7 days prior to registration and must agree to practice adequate contraception as defined below. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), includes any female who has had:\r\n* A hysterectomy\r\n* A bilateral oophorectomy\r\n* A bilateral tubal ligation\r\n* Is post-menopausal: Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L).Xx_NEWLINE_xXSubjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT.Xx_NEWLINE_xXPostmenopausal is defined either by age >= 60, prior bilateral oophorectomy, or age < 60 with intact uterus and no spontaneous menses over 12 consecutive months; follicule stimulating hormone (FSH) and luteinizing hormone (LH) will not be utilized to define menopausal status, unless history of prior total hysterectomy; premenopausal patients are eligible to participate; medication-induced amenorrhea will not categorize a patient as post-menopausal; these patients should be treated as pre-menopausal; premenopausal and peri-menopausal patients should receive ongoing treatment with luteinizing hormone-releasing hormone (LHRH) agonists (goserelin or leuprolide); premenopausal patients must be enrolled directly into the treatment phase of the studyXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening; WOCBP must agree to use adequate contraception (barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; WOCBP should use an adequate method to avoid pregnancy for 7 months after the last dose of investigational drug; women must not be breastfeeding; women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediatelyXx_NEWLINE_xXFemale subject of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to registration; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potentialXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXpost-menopausal (defined as at least 1 year without any menses) prior to Screening, orXx_NEWLINE_xXPostmenopausal status or receiving ovarian ablation with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin\r\n* Postmenopausal status is defined by any one of the following criteria:\r\n** Prior bilateral oophorectomy\r\n** Age >= 60 years\r\n** Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone (FSH), luteinizing hormone (LH), and estradiol in the postmenopausal range per local normal\r\n* If the patient does not meet criteria for postmenopausal status but is receiving ovarian ablation therapy with a GnRH agonist such as goserelin, the patient is eligible for this study, provided that the GnRH agonist is started at least 2 weeks prior to cycle 1 day 1 (C1D1) of anti-estrogen therapyXx_NEWLINE_xXFertile men or women of childbearing potential unless 1) permanently sterile or 2) using a highly effective measure of contraception such as condoms in males and consistent and correct use of one of the following in females: intrauterine device, tubal sterilization, Essure micro-insert system, vasectomy in the male partner; effective contraception is required for males during treatment with study drug and to continue for 3 months after the last dose of either entospletinib or obinutuzumab, whichever is later; for women, effective contraception is required to continue for >= 12 months after the last dose of obinutuzumab or for 30 days after the last dose of entospletinib, whichever is later; for men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment\r\n* Definition of childbearing potential: for this study, a female subject is considered of childbearing potential until becoming post-menopausal unless permanently sterile or with medically documented ovarian failure; women are considered to be in a postmenopausal state when >= 54 years of age with cessation of previously occurring menses for >= 12 months without an alternative cause; women of any age with amenorrhea of >= 12 months may also be considered post-menopausal if their follicle stimulating hormone (FSH) level is in the post-menopausal range and they are not using hormonal contraception or hormonal replacement therapy; permanent sterilization in females includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy in a female subject of any age; permanent sterilization in males include bilateral orchiectomy or medical documentation of alternative explanationXx_NEWLINE_xXNote: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age ? 60; Age < 60 and amenorrheic for ? 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.Xx_NEWLINE_xXFemale patients of childbearing potential and male patients able to father children who have female partners of childbearing potential must agree to use one highly effective method (defined as less than 1% failure rate per year) and one additional effective method of contraception from 15 days prior to first trial treatment administration until at least 30 days after study participant’s final dose of avelumab; females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without an alternative medical cause); post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women; male patients able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy)Xx_NEWLINE_xXWomen who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within 72 hours prior to initiating study treatment; Note: postmenopausal is defined as any of the following:\r\n* Age >= 60 years\r\n* Age < 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n* Bilateral oophorectomyXx_NEWLINE_xXPostmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression; pre- or peri- menopausal subjects must have a negative urine pregnancy test confirmed at screeningXx_NEWLINE_xXPost-menopausal: defined as more than 50 years-of-age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatmentsXx_NEWLINE_xXWomen under 50 years-of-age would be considered postmenopausal if they have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone and luteinizing hormone levels in the postmenopausal range for the institution.Xx_NEWLINE_xXPostmenopausal status is defined either by: I). Prior bilateral oophorectomy OR ii). Age ? 60 OR iii). Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range. Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure menopausal status.Xx_NEWLINE_xXPremenopausal status is defined as either: I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.Xx_NEWLINE_xXPostmenopausal women\r\n* Postmenopausal if satisfies one or more of the following criteria: age greater than 52 years of age; having had a bilateral oophorectomy; amenorrhoeic for at least 12 monthsXx_NEWLINE_xXPost-menopausal defined as\r\n* Age >= 60 and amenorrhea > 12 consecutive months, OR\r\n* Age < 60 and amenorrhea > 12 consecutive months without another cause and documented follicle stimulating hormone (FSH) level within post-menopausal range according to institutional standard, OR\r\n* Previous bilateral oophorectomyXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy; subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow upXx_NEWLINE_xXReproductive criteria: 1. A male subject with female partner of child bearing potential must agree to use one of the methods of contraception for the duration specified in protocol. 2. A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not nursing, and at least one of the following conditions apply: Reproductive potential: subject must agree to follow one of the options and the duration specified in protocol; Non-reproductive potential defined as i) Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy; ii) Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical profile or females over 60 years of age. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.Xx_NEWLINE_xXPHASE I: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal); post-menopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50,\r\n* Radiation-induced oophorectomy with last menses > 1 year ago,\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses, or\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXPHASE II SCLC: Women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal); post-menopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\n* LH and FSH levels in the post menopausal range for women under 50,\r\n* Radiation-induced oophorectomy with last menses > 1 year ago,\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses, or\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXUROTHELIAL CARCINOMA EXPANSION COHORT: Women of childbearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 120 days (both male and female) following last dose of study drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; fertile females of childbearing potential are defined as women physically capable of becoming pregnant unless the female patient cannot have children because of surgery or other medical reasons (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal); post-menopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments,\r\n* LH and FSH levels in the post menopausal range for women under 50,\r\n* Radiation-induced oophorectomy with last menses > 1 year ago,\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses, or\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXFemale subjects who are of non-reproductive potential (ie, post menopausal by history - no menses for ? 1 year and follicle-stimulating hormone (FSH) level consistent with post-menopausal status; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).Xx_NEWLINE_xXFemales should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments \r\n* Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply: \r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXWomen may be premenopausal or postmenopausal; however, premenopausal women and men must be treated with concurrent luteinizing hormone-releasing hormone (LHRH) agonist (goserelin preferred) initiated at least 4 weeks prior to enrollment; NOTE: Postmenopausal status is defined by at least one of the following criteria:\r\n* Age >= 60 years\r\n* Age < 60 and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females\r\n* Documented bilateral oophorectomy; or,\r\n* Medically confirmed ovarian failureXx_NEWLINE_xXFemale subject not of childbearing potential is defined as follows:\r\n* Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n* Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years oldXx_NEWLINE_xXPost-menopausal status defined by: a) age ? 60 years; b) age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; c) documented bilateral oophorectomy; d) medically confirmed ovarian failure OR\r\n* Pre/peri-menopausal, ie, not meeting the criteria for being postmenopausal who are also receiving ongoing treatment with gonadotrophin releasing hormone (LHRH) agonists (goserelin or leuprolide); the first injection should occur at least two weeks before study startXx_NEWLINE_xXPost-menopausal defined as\r\n* Age >= 55 years and 1 year or more of amenorrhea\r\n* Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL\r\n* Surgical menopause with bilateral oophorectomyXx_NEWLINE_xXWomen who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within 7 days prior to initiating study treatment; Note: Postmenopausal is defined as one or more of the following:\r\n* Age >= 60 years\r\n* Age < 60 years and amenorrheic for at least 1 year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n* Bilateral oophorectomyXx_NEWLINE_xXPost-menopausal women with clinical stage I-IV, ER positive/HER2 negative, breast cancer that will be managed by surgical resection; the subject is post-menopausal if:\r\n* She has had a prior bilateral oophorectomy\r\n* Age is 60 or greater\r\n* Age is under 60 but she has had at least 12 months or amenorrhea and with both follicle-stimulating hormone and estradiol levels in the post-menopausal range; treatment with a luteinizing hormone-releasing hormone is not allowed for induction of ovarian suppression on this trial\r\n* Patients with metastatic disease at diagnosis are eligible if clinically appropriate; the patient must have had a baseline magnetic resonance imaging (MRI) performed as standard-of-care that can be used to calculate the distance(s) of the longest dimension(s) of the primary tumor(s)Xx_NEWLINE_xXWOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXWomen of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mIU/mLXx_NEWLINE_xXWomen who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard MCC-VCUHS BMT Program guidelinesXx_NEWLINE_xXFemale subjects must either be of non-reproductive potential or must have a negative serum pregnancy test within 7 days prior to registration on study; evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXWomen of childbearing potential are defined as follows: having regular menstrual cycles; has amenorrhea, irregular menstrual cycles or using a contraceptive method that precludes withdrawal bleeding; have had a tubal ligation; women are considered not to be of childbearing potential for the following reasons: had hysterectomy and/or bilateral oophorectomy; post-menopausal defined by amenorrhea for at least 1 year in a woman > 45 years oldXx_NEWLINE_xXPostmenopausal status, as defined by the National Comprehensive Cancer Network\r\n* Age > 60 years old OR\r\n* Prior bilateral oophorectomy regardless of age\r\n* If patient < 60 years old and amenorrheic for > 12 months or in the absence of ovarian suppression, follicle-stimulating hormone (FSH) and estradiol have to be in the postmenopausal rangeXx_NEWLINE_xXFemale patients are considered to be of childbearing potential unless:\r\n* They are post-menopausal (defined as older than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments)\r\n* There is documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (but not tubal ligation), or\r\n* They are 50 years or younger but have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution\r\n** Female patients who are of childbearing potential must agree to use adequate contraceptive measures (as defined below) for the duration of study participation, and for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician; they also may not be breast feeding and must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment\r\n** Male patients who are sexually active with a female partner of childbearing potential must be either surgically sterilized or agree to use barrier contraception (i.e., condoms) for the duration of study participation, and for 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physicianXx_NEWLINE_xXFemale patients should be either:\r\n* Postmenopausal, as defined by at least one of the following criteria:\r\n* Age >= 60 years\r\n* Age =< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause\r\n* Documented bilateral oophorectomy\r\n* Medically confirmed ovarian failure\r\nOR\r\n* Pre/peri-menopausal women, ie, not meeting the criteria for being postmenopausal who are also receiving ongoing treatment with luteinizing hormone-releasing hormone (LHRH) agonists (goserelin or leuprolide); the first injection should occur at least two weeks before study startXx_NEWLINE_xXNOTE: “Women of childbearing potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mlXx_NEWLINE_xXEvidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1; postmenopausal is define as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXFor patients who are not postmenopausal or surgically sterile (absence of ovaries and/or uterus), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment or 3 months after discontinuation of taselisib and/or enzalutamide, whichever is longer; hormone based oral contraceptives are not allowed on study; postmenopausal is defined as:\r\n* Age >= 60 years\r\n* Age =< 60 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal rangeXx_NEWLINE_xXPostmenopausal with last natural menses > 24 months priorXx_NEWLINE_xXPatients must be post-menopausal based on either a history of an oophorectomy, or at least one year of amenorrhea; an elevated serum gonadotropin level can be used to confirm menopausal status in a subject with one year or more of amenorrheaXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, orXx_NEWLINE_xXA female subject is eligible to participate if she is of: a) non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] > 40 MlU/mL and estradiol < 40 pg/mL [< 140 pmol/L] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods listed below if they wish to continue their HRT during the study; otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment; for most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT; following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; b) child-bearing potential and agrees to use one of the contraception methods listed below for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point; female subjects must agree to use contraception until 4 weeks after the last dose of study medication, and must have a negative serum or urine pregnancy test within 14 days prior to the start of dosingXx_NEWLINE_xXPostmenopausal or premenopausal; \r\n* NOTE: Postmenopausal women, verified by: \r\n** Bilateral surgical oophorectomy, or \r\n** No spontaneous menses >= 1 year or \r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards; \r\n* Premenopausal women, verified by: \r\n** Regular menses, or \r\n** FSH and estradiol levels in premenopausal range, according to institutional standardsXx_NEWLINE_xXFemales must have a negative serum pregnancy test 24 hours prior to the start of treatment or be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months)Xx_NEWLINE_xXPost-menopausal status defined by any of the following:\r\n* Age > 55 years\r\n* History of bilateral oophorectomy\r\n* Spontaneous amenorrhea for 1 year with intact uterus and ovaries\r\n* Serum estradiol and follicle-stimulating hormone (FSH) concentrations in the post-menopausal range, along with either amenorrhea for 6 months or previous hysterectomyXx_NEWLINE_xXPostmenopausal womanXx_NEWLINE_xXSubjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)Xx_NEWLINE_xXSubjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRTXx_NEWLINE_xXFemale subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child- bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\r\n* Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\r\n* Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXWomen who are pregnant or lactating. NOTE: Women of childbearing potential (WOCBP) must have a \negative\ serum pregnancy test within one week prior to treatment. a) Women not OCBP defined as any of the following: i) Postmenopausal with > 1 year since last menses and: (1) If younger than 65 years old, with a follicle-stimulating hormone (FSH) > 40 mIU/mL (2) If older than 65 years old and not on hormone replacement therapy (HRT), with a FSH > 30 mIU/mL (3) If older than 65 years old and on HRT, the FSH requirement in not applicable. Postmenopausal females on HRT will be allowed if the treatment is stable for at least 6 months prior to dosing of study drug(s) (4) Written medical documentation of being sterilized (e.g. hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed at least 6 months prior to dosing study drug(s). Note: Tubal ligation is not considered a form of permanent sterilization (5) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.Xx_NEWLINE_xXpostmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to Screening, orXx_NEWLINE_xXPostmenopausal defined as women >54 years of age with amenorrhea for ? 2 years prior to screeningXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients is required; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced oophorectomy with last menses > 1 year ago, had chemotherapy-induced menopause with > 1-year interval since last menses, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXPostmenopausal defined as:Xx_NEWLINE_xXAge 55 years and 1 year or more of amenorrhea with LH and/or FSH levels in the postmenopausal rangeXx_NEWLINE_xXAge 55 with prior hysterectomy but intact ovaries with LH and/or FSH levels in the postmenopausal rangeXx_NEWLINE_xXOf non-childbearing potential defined as women who have had a hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or are documented postmenopausal (follicle stimulating hormone > 40 mIU/mL); OR, Of childbearing potential defined as including women < 55 years of age, even those who have experienced 2 years of amenorrhea; all women should also meet both of the following criteria:Xx_NEWLINE_xXFor Part 1, postmenopausal women onlyXx_NEWLINE_xXFor Part 2, any menopausal statusXx_NEWLINE_xXPrior to the discovery of the breast cancer, clinically post?menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference rangeXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXSubjects must either be of non-reproductive potential (ie, post-menopausal by history; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum or urine pregnancy test upon study entry; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >/= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXNegative serum or urine pregnancy test done =< 7 days prior to registration and repeated prior to dosing on day 1 of each cycle, for individuals of childbearing potential only; NOTE: Individuals are considered to be of childbearing potential unless one of the following applies:\r\n* Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause; a high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU/mL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state: or\r\n* Considered to be permanently sterile; permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomyXx_NEWLINE_xXPostmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days and within 72 hours of study treatment and confirmed prior to receiving treatment on this study. Patients with positive results will be removed from the study. Postmenopausal is defined as: 1. amenorrheic for 1 year or more following cessation of exogenous hormonal treatments. 2. luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50. 3. radiation-induced oophorectomy with last menses > 1 year ago. 4. chemotherapy-induced menopause with >1 year interval since last menses. 5. surgical sterilization (bilateral oophorectomy or hysterectomy). 6. female patients must agree to use a highly effective birth control method while on study and for at least 1 month after your last dose of study drug(s).Xx_NEWLINE_xXFemale patients of childbearing potential are not willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception is defined as:\r\n* Surgical birth control/sterilization (such as male vasectomy or female sterilization.\r\n* Birth control pills, injections, implants, or patches.\r\n* Intrauterine devices (IUDs).\r\n* Two barrier methods (male condom and female diaphragm, cervical cap, or sponge) in combination with a spermicide.\r\n* Highly effective contraception must be used by both sexes during the study and must be continued for 3 months after the last dose of study treatment. (Women of not childbearing potential: post-menopausal [age > 55 years with cessation of menses > 12 months or < 55 years but not spontaneous menses for at least 2 years or < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of \postmenopausal range\ for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).Xx_NEWLINE_xXNon pregnant: negative serum test for pregnancy, unless male, prior hysterectomy, tubal ligation, or postmenopausal; (Note: postmenopausal is defined as age > 55 with amenorrhea for > 1 year or age < 55 years with amenorrhea for 2 years and follicle stimulating hormone (FSH) level within postmenopausal range of institutional parameters; patients requiring FSH level to determine menopausal status need not have this performed and may choose to proceed with serum pregnancy testing)Xx_NEWLINE_xXPatient is postmenopausal woman defined as either:Xx_NEWLINE_xXAge <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and/or estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age <60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range. Note: For women using therapy-induced amenorrhea other than ovarian radiation, goserelin or leuprolide, etc., serial measurements of FSH and/or estradiol are needed to ensure menopausal statusXx_NEWLINE_xXFor women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to step 1 registration; Note: women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply: \r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXPost-menopausal subjects as defined by any of the following:\r\n* Subjects at least 55 years of age\r\n* Subjects under 55 years of age and amenorrheic for at least 12 months or follicle-stimulating hormone (FSH) values >= 40 IU/L and estradiol levels =< 20 IU/L\r\n* Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 monthsXx_NEWLINE_xXWomen of child-bearing potential are expected to use highly effective contraception during the study and for 1 month after the last dose of study drug; postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; “women of reproductive potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXPostmenopausal or evidence of non-pregnant status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to the start of therapy; postmenopausal status is defined as:\r\n* Age >= 60 years, or\r\n* Age < 60 with any one or more of the conditions below:\r\n** Amenorrheic for >= 1 year in the absence of chemotherapy and/or hormonal treatments,\r\n** Luteinizing hormone and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range,\r\n** Radiation-induced oophorectomy with last menses > 1 year ago,\r\n** Chemotherapy-induced menopause with > 1 year interval since last menses,\r\n** Surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXWomen of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 28 days of registration; the patient and her sexual partner(s) must agree to use adequate contraception when sexually active for the duration of the study and for 6 months after finishing study drug; a woman is considered of childbearing potential following menarche and until becoming post-menopausal unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone (FSH) level in the postmenopausal range maybe used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapyXx_NEWLINE_xXSubject is post-menopausal defined as age over 60 or status post bilateral oophorectomy; in subjects aged 50-60 years they shall be considered eligible if follicle stimulating hormone (FSH)/luteinizing hormone (LH) and estradiol is within institutional post-menopausal range at the time of study entryXx_NEWLINE_xXBe postmenopausal (defined as amenorrheic for at least 12 months)Xx_NEWLINE_xXWomen are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; for women with therapy-induced amenorrhea, oophorectomy or serial measurements of follicle stimulating hormone (FSH) and/or estradiol are needed to ensure postmenopausal status; NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppressionXx_NEWLINE_xXPatients may be premenopausal or postmenopausal at the time of randomization; for study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomyXx_NEWLINE_xXEvidence of non-childbearing status for women of childbearing potential, or postmenopausal status: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses\r\n* Or surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXPatients must be postmenopausal defined as:\r\n* Age >= 55 years and one year or more of amenorrhea\r\n* Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/mL\r\n* Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration)\r\n* The use of gonadotropin-releasing hormone (GnRH) analogues to achieve postmenopausal status is not allowedXx_NEWLINE_xXFor female subjects to be considered as not having childbearing potential, they must meet 1 or more of the following criteria: \r\n* Postmenopausal for at least 24 consecutive months; \r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy); \t\r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mLXx_NEWLINE_xXFor female subjects to be considered as not having childbearing potential, they must meet 1 or more of the following criteria: \r\n* Postmenopausal for at least 24 consecutive months\r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy) \r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mLXx_NEWLINE_xXpost-menopausal (defined as at least 1 year without any menses) prior to Screening, orXx_NEWLINE_xXhave postmenopausal statusXx_NEWLINE_xXFollicle stimulating hormone measurement elevated into the menopausal rangeXx_NEWLINE_xXWomen of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and 8 weeks after the final dose of study treatment; highly effective contraception methods include:\r\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment; in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment \r\n* Male partner sterilization (at least 6 months prior to screening); for female subjects on the study the vasectomized male partner should be the sole partner for that subject\r\n* Combination of the following methods:\r\n** Placement of an intrauterine device (IUD) or intrauterine system (IUS)\r\n** Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository\r\n* Note: Post-menopausal women are allowed to participate in this study; women are considered post-menopausal and not of child bearing potential if they are:\r\n** Aged >= 60;\r\n** Or aged < 60 and have had 12 months of natural (spontaneous, in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) amenorrhea with and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range (serum FSH > 40 mIU/mL and estradiol < 10 pg/mL or according to the postmenopausal range definition for the local laboratory involved)\r\n** Or have had surgical bilateral oophorectomy (with or without hysterectomy)\r\n* For women with therapy-induced amenorrhea, oophorectomy or serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status; NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppressionXx_NEWLINE_xXNegative pregnancy test (serum or urine) for women of childbearing potential (WOCBP) • Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months or with bilateral tubal ligationXx_NEWLINE_xXIf letrozole is selected as the control therapy, patients must be postmenopausal, either following bilateral oophorectomy or at least 5 years after spontaneous menopause; patients within 5 years of spontaneous menopause or who have had a hysterectomy without bilateral oophorectomy must have postmenopausal luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels; patients on hormone replacement therapy (HRT) must agree to withdrawal of hormone therapy before letrozole is startedXx_NEWLINE_xXPostmenopausal women. Postmenopausal status is defined by the National Comprehensive Cancer Network as either:Xx_NEWLINE_xXAge < 55 years and surgical menopause with bilateral oophorectomy a. Note: Ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression at the time of screening. Long term use (>6 months prior to screening) is permittedXx_NEWLINE_xXPost-menopausalXx_NEWLINE_xXPostmenopausal status as defined by the protocolXx_NEWLINE_xXWomen must be postmenopausal\r\n* Postmenopausal status is verified by:\r\n** Prior bilateral surgical oophorectomy, or\r\n** Age >= 60 years, or\r\n** Age < 60 with no menses for > 1 year with follicle-stimulating hormone (FSH) and estradiol levels within post menopausal range, according to institutional standardXx_NEWLINE_xXDocumentation of menopausal status: post menopausal or premenopausal subjects are eligible.Xx_NEWLINE_xXA female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 milli international unit/mL and estradiol less than 40 pg/mL (less than 140 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential and agrees to use one of the contraception methods (described in the protocol) for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication; Negative serum pregnancy test <=7 days prior to first study drug dose; Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK525762 or at least 28 days (whichever is longer) following the last dose of study treatment.Xx_NEWLINE_xXAmenorrheic for > 2 years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluationXx_NEWLINE_xXBe of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)Xx_NEWLINE_xXPostmenopausal women. Postmenopausal status is defined either by:Xx_NEWLINE_xXAge <60 years with amenorrhea for at least 12 months and both follicle-stimulating hormone (FSH) and estradiol levels are in postmenopausal range (according to the local laboratory)Xx_NEWLINE_xXPost-, pre- or peri-menopausal women considered to be in the post?menopausal state as defined by one of the following:Xx_NEWLINE_xXAge < 60 years and cessation of regular menses for at least 12 consecutive months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and serum estradiol and follicle-stimulating hormone (FSH) level within the post-menopausal rangeXx_NEWLINE_xXFor female subjects to be considered as not having childbearing potential, they must meet 1 or more of the following criteria:\r\n* Postmenopausal for at least 24 consecutive months\r\n* Surgically sterile (ie, have had a hysterectomy or bilateral oophorectomy)\r\n* Females with irregular menstrual periods and/or on hormone replacement therapy must have a documented serum follicle stimulating hormone level > 35 mIU/mLXx_NEWLINE_xXFor women who are not postmenopausal (< 12 months of non therapy-induced amenorrhea, with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus): agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate non hormonal methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 4 months after the last dose of study drugXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXFemale subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec; (women of not childbearing potential: post-menopausal [age > 55 years with cessation of menses > 12 months or < 55 years but not spontaneous menses for at least 2 years or < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of \postmenopausal range\ for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)Xx_NEWLINE_xXAre postmenopausal for at least 1 year before the Screening visit , orXx_NEWLINE_xXFor women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods as specified in protocolXx_NEWLINE_xXPatients must be post-menopausal women, as defined in the protocolXx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXPatient is postmenopausalXx_NEWLINE_xXHave postmenopausal statusXx_NEWLINE_xXPostmenopausal statusXx_NEWLINE_xXAny menopausal statusXx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXPostmenopausal women defined by at least one of the following criteria:\r\n* Prior bilateral oophorectomy OR amenorrheic for >= 12 months (if =< 55 years of age and prior to chemotherapy, or on medical ovarian ablative therapy\r\n* Previous hysterectomy with one or both ovaries left in place (previous hysterectomy in which documentation of bilateral oophorectomy is unavailable AND FSH values consistent with the institutional normal values for the post-menopausal state; FSH levels must be obtained within 28 days prior to registration)Xx_NEWLINE_xXPostmenopausal (defined as at least 1 year without any menses) prior to screening, orXx_NEWLINE_xXOnly postmenopausal women will be eligible; subjects will be classified as being postmenopausal if they have had:\r\n* Bilateral surgical oophorectomy, or\r\n* No spontaneous menses > 1 year or\r\n* No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standardsXx_NEWLINE_xXPostmenopausal status, defined as any one of the following criteria:\r\n* Documented history of bilateral oophorectomy\r\n* Age 60 years or more\r\n* Age 45 to 59 and satisfying one or more of the following criteria:\r\n** Amenorrhea for at least 12 months and intact uterus\r\n** Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) and estradiol concentration within postmenopausal range including:\r\n*** Patients who have had a hysterectomy\r\n*** Patients who have received hormone replacementXx_NEWLINE_xXWomen of non-childbearing potential may be included if they are either surgically sterile or considered postmenopausal; women who have documentation of at least 12 months of spontaneous amenorrhea and have an follicle stimulating hormone (FSH) level > 40 mIU/mL will be considered postmenopausalXx_NEWLINE_xXIs not post-menopausal (defined as amenorrhea >12 consecutive months).Xx_NEWLINE_xXWomen of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; additionally, women under the age of 62 who are not surgically sterile must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to document postmenopausal status\r\n* WOCBP must agree to use appropriate method(s) of contraception for 6 months after the last dose of study treatment, per Food and Drug Administration (FDA) recommendations on use of contraception following bevacizumab; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediatelyXx_NEWLINE_xXFemale patients must be willing to use 2 forms of highly effective contraception (per institution standards) from the time of screening until 4 weeks after discontinuing study, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child bearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: (1) post-menopausal women, defined as either women aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments, or, (2) women under 50 years old who have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution; alternatively, women must have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation; male patients should either be surgically sterile or willing to use an effective barrier method of contraception during the study and for 16 weeks following the last dose of study treatment if sexually active with a female of childbearing potential; if not done previously, storage of sperm prior to receiving AZD2014 will be advised to male patients with a desire to have childrenXx_NEWLINE_xXFemales of childbearing potential must have a negative serum pregnancy test within 72 hours (hrs) prior to treatment; NOTE: Females are considered of child bearing potential unless they are surgically sterile, have a congenital acquired condition that prevents childbearing (have undergone a hysterectomy, bilateral tubal ligation/occlusion, bilateral salpingectomy or bilateral oophorectomy at least 6 weeks prior to screening) or they are naturally postmenopausal for at least 12 consecutive months without an alternative medical cause; in women < 45 years of age a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy; in the absence of 12 months of amenorrhea, a single follicle stimulating hormone (FSH) measurement is insufficientXx_NEWLINE_xXA female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, or documented bilateral tubal oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 units (U)/mL and estradiol <40 picograms (pg)/mL (<140 picomoles (pmol)/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 7 months after the last dose of study medication. Negative serum pregnancy test <=7 days prior to first study drug dose. Female subjects who are lactating must discontinue nursing prior to the first dose of study treatment and must refrain from nursing throughout the treatment period and for 5 half-lives of GSK2820151 or at least 28 days (whichever is longer) following the last dose of study treatment.Xx_NEWLINE_xXNot of childbearing potential: postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening with follicle-stimulating hormone [FSH] > 40 IU/L for women < 55 years of age at Screening), or documented to be surgically sterile or status posthysterectomy (at least 1 month prior to Screening).Xx_NEWLINE_xXWomen are eligible to participate if: non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] > 40 MlU/mL and estradiol < 40 pg/mL [< 140 pmol/L] is confirmatory); females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study; otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment; for most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRTXx_NEWLINE_xXPostmenopausal women are eligible; postmenopausal is defined as any of the following:\r\n* Age >= 60 years\r\n* Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range per local normal range\r\n* Premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist for at least 3 consecutive months prior to study entry are eligible; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment\r\n* Status-post bilateral oophorectomy-after adequate healing post surgeryXx_NEWLINE_xXSubject is considered postmenopausalXx_NEWLINE_xXFemale subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potentialXx_NEWLINE_xXFor women: Negative pregnancy test during screening (Day 3 to Day 1) before C1D1 and compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for ?12 consecutive months; or receiving hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level >35 mIU/mL).Xx_NEWLINE_xXPatients must be postmenopausal women defined as: Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or Age 55 or younger with no menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Age greater than or equal to 18 with documented bilateral oophorectomy.Xx_NEWLINE_xXPremenopausal or peri-menopausal women.Xx_NEWLINE_xXPostmenopausal defined as no menses for 12 or more months without an alternative medical cause ORXx_NEWLINE_xXBoth pre- and postmenopausal women will be included in this study; premenopausal will be defined as < 6 months since last menstrual period, no prior bilateral oophorectomy, and no use of hormone replacement therapy; postmenopausal status will be defined as the absence of menses for > 12 months, serum follicle-stimulating hormone (FSH) > 20 mIU/ml, or history of bilateral oophorectomy; perimenopausal women will be excluded, defined as menstrual cycle irregularity (variable cycle length that differs from normal by more than 7 days) and an FSH > 20 mIU/mlXx_NEWLINE_xXPostmenopausal women (women are considered post-menopausal and not of child-bearing potential if they are > 18 years of age and have had 12 months of natural [spontaneous] amenorrhea with an appropriate clinical profile [e.g. age appropriate, history of vasomotor symptoms or biochemically postmenopausal by estradiol and follicle stimulating hormone (FSH) levels]) prior to enrollment or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to registration; medical ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists to render a patient postmenopausal will not be acceptableXx_NEWLINE_xXPost-menopausal women, as verified by:\r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >= 1 year, or\r\n* No menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standardsXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXMen and pre- and postmenopausal women are eligibleXx_NEWLINE_xXPatient is postmenopausal. Postmenopausal status is defined either by:Xx_NEWLINE_xXAge <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.Xx_NEWLINE_xXpost-menopausal (defined as at least 1 year without any menses) prior to Screening, orXx_NEWLINE_xXPostmenopausal or evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.\r\n* Postmenopausal is defined as any one or more of the following:\r\n** Age >= 60 years.\r\n** Age < 60 and amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatment.\r\n** Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 60.\r\n** Radiation-induced oophorectomy with last menses > 1 year ago.\r\n** Chemotherapy-induced menopause with > 1 year interval since last menses.\r\n** Surgical sterilisation (bilateral oophorectomy or hysterectomy).Xx_NEWLINE_xXWomen who are breast feeding or pregnant\r\n* Men or women of reproductive potential who are not willing to employ effective birth control from screening to 30 days after the last dose of study drugs; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate\r\nFor a female patient to be considered as not of child bearing potential, she should fulfill one of the following:\r\n* Post-menopausal women, defined as either women aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, or, women under 50 years old who have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution Or\r\n* Have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (but not tubal ligation)Xx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXIs a surgically sterile male or female, or is postmenopausal for at least 1 year, at least 50 years of age, with a follicle-stimulating hormone level > 40 milli-International units per mL (mIU/mL)Xx_NEWLINE_xXPostmenopausal women, as defined by one of the following (estradiol assay cutoff takes into account that the patient is on aromatase inhibitor therapy):\r\n* Age >= 55 years and one year or more of amenorrhea\r\n* Age < 55 years and one year or more of amenorrhea, with an estradiol assay within the post-menopausal range\r\n* Age < 55 years with prior hysterectomy but intact ovaries, with an estradiol assay within the post-menopausal range\r\n* Surgical menopause with bilateral oophorectomy\r\n* Ovarian suppression with a luteinizing hormone-releasing hormone (LH-RH) agonist, with an estradiol assay within the post-menopausal range at baseline and periodically on-studyXx_NEWLINE_xXPatients must be post-menopausal; post-menopausal female subjects should be defined prior to protocol enrollment by any of the following:\r\n* Subjects at least 55 years of age; OR\r\n* Subjects under 55 years of age and naturally (spontaneous) amenorrhea for at least 12 months or follicle-stimulating hormone (FSH) values >= 40 IU/L and estradiol levels =< 20 IU/L; OR\r\n* Prior bilateral oophorectomy; OR\r\n* Prior radiation castration with amenorrhea for at least 6 months\r\n* NOTE: Treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (such as goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppressionXx_NEWLINE_xXMenopausal at study entry as described by: \r\n* Surgical menopause (TAH/BSO), or\r\n* Age >= 50 years and cessation of menstruation for at least 1 year, or\r\n* Age < 50 years and cessation of menstruation for at least 1 year with estradiol level in post-menopausal range, or\r\n* Rendered post-menopausal with the use of luteinizing hormone-releasing hormone (LHRH) agonistXx_NEWLINE_xXFemales of childbearing potential must have a negative pregnancy test =< 7 days prior to registration, unless they are surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (follicle-stimulating hormone [FSH] >30 U/mL)Xx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXPostmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses [amenorrheic] within 12 months of randomization [e.g., spontaneous or secondary to hysterectomy] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)Xx_NEWLINE_xXWere postmenopausal for at least 24 months before the screening visit, ORXx_NEWLINE_xXPostmenopausal women are eligible; postmenopausal is defined as any of the following:\r\n* Age > 60 years\r\n* Age > 45 with intact uterus and amenorrhea for 12 months or more\r\n* Follicle stimulating hormone (FSH) levels within postmenopausal range according the ranges established by the testing facility\r\n* Premenopausal women who have been on a gonadotropin-releasing hormone (GnRH) agonist for at least 3 consecutive months prior to study entry are eligible; women in this group MUST remain on the GnRH agonist for the duration of protocol treatment\r\n* Status-post bilateral oophorectomy after adequate healing post-surgeryXx_NEWLINE_xXPost-menopausal status over 1 yearXx_NEWLINE_xXPostmenopausal women defined by one of the criteria:\r\n* No spontaneous menses for at least 12 months if the subject is >= 50 years old\r\n* Amenorrheic for at least 12 months if the subject is < 50 years old, with serum estradiol within the institutional postmenopausal range\r\n* Bilateral oophorectomy\r\n* If prior hysterectomy but intact ovaries, must be >= 55 years old, or have serum estradiol within the postmenopausal range\r\n* If premenopausal, must be on a gonadotropin-releasing hormone (GnRH) agonist (leuprolide or goserelin) with serum estradiol levels within the institutional postmenopausal rangeXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post-menopausal is defined as:\r\n * Amenorrhea >= 12 consecutive months without another cause, or\r\n * For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mLXx_NEWLINE_xXPostmenopausalXx_NEWLINE_xXA female patient is eligible to enter and participate in the study if she is:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any woman who:\r\n ** Has had a hysterectomy, or\r\n ** Has had a bilateral oophorectomy (ovariectomy), or\r\n ** Has had a bilateral tubal ligation, or\r\n ** Is post-menopausal\r\n*** Patients not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L)\r\n*** Patients using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT\r\n* Childbearing potential, including any female who has a negative serum or urine pregnancy test within 14 days prior to the first dose of study treatment and agrees to one of the following:\r\n ** An intrauterine device with a documented failure rate of less than 1% per year.\r\n ** Vasectomized partner who is sterile prior to the patient’s entry and is the sole sexual partner for that woman.\r\n ** Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, throughout the clinical trial, and for at least 21 days after the last dose of investigational product.\r\n ** Double barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; or diaphragm with spermicide; or male condom and diaphragm.\r\n ** Oral contraceptive, either combined or progestogen alone\r\n ** Injectable progestogen\r\n ** Implants of levonorgestrel\r\n ** Estrogenic vaginal ring\r\n ** Percutaneous contraceptive patchesXx_NEWLINE_xXFemale patients must either be: post-menopausal women as defined by a. age >= 60 years of age; b. prior bilateral oophorectomy; c. age < 60 with at least 12 months of spontaneous amenorrhea or post-menopausal range follicle-stimulating hormone (FSH) and estradiol levels OR premenopausal women receiving a gonadotropin-releasing hormone agonistXx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:\r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\r\n* A positive serum pregnancy test must be confirmed by a pelvic ultrasound (US) since some non-seminomatous germ cell tumors (NSGCT) may secrete beta-hCG and cause a false positive pregnancy; a pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do soXx_NEWLINE_xXStudy subjects should be post-menopausal women (premenopausal women are eligible if they are on or willing to be on mandatory ovarian function suppression)Xx_NEWLINE_xXof non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); orXx_NEWLINE_xXFemales of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or those who are postmenopausal (defined as 12 months with no menses without an alternative medical cause or follicle-stimulating hormone/luteinizing hormone levels consistent with a menopausal state)Xx_NEWLINE_xXFemales or female partners not of childbearing potential must have been surgically sterilized or postmenopausal (as defined above in inclusion criterion #12). Sterilized males must be at least 1 year post vasectomyXx_NEWLINE_xXPositive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feedingXx_NEWLINE_xXBe of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterileXx_NEWLINE_xXPostmenopausal (defined as at least 1 year without any menses) prior to screening, orXx_NEWLINE_xXWomen of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of nivolumab\r\n* “Women of childbearing potential” is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\r\n* Menopause is defined as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; if menopausal status is considered for the purpose of evaluating childbearing potential, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level > 40 mIU/mL, in order to be considered postmenopausal and not of childbearing potentialXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXWomen for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated; women must be either post-menopausal, or premenopausal having undergone oophorectomyXx_NEWLINE_xXPatient is postmenopausal or premenopausal\r\n* NOTE: postmenopausal women, verified by\r\n** Bilateral surgical oophorectomy, or\r\n** No spontaneous menses >= 1 year or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards or\r\n* Premenopausal women, verified by:\r\n** Regular menses or\r\n** FSH and estradiol levels in premenopausal range, according to institutional standardsXx_NEWLINE_xXIn premenopausal women, serum estradiol level in postmenopausal range =< 7 days prior to registrationXx_NEWLINE_xXAge >= 50 years and postmenopausal with no menses for at least one year prior to study enrollmentXx_NEWLINE_xXPost-menopausalXx_NEWLINE_xXWomen of child-bearing potential (i.e. =< 50 years of age or has had menstrual cycle within the past 12 months, if > 50 years of age; if in doubt, check follicle-stimulating hormone [FSH], luteinizing hormone [LH], and estradiol level) must have a negative urine or serum pregnancy test at screeningXx_NEWLINE_xXReproductive status for cohort 2: HR+ stage IV post-menopausal breast cancer; post-menopausal is defined by at least one of the following criteria:\r\n* Prior bilateral oophorectomy OR amenorrheic for >= 12 months (if =< 55 years of age and prior chemotherapy or on medical ovarian ablative therapy or received ovarian radiation for ablation in the past 5 years and/or tamoxifen or an aromatase inhibitor [AI] within the past year, then follicle-stimulating hormone [FSH] and estradiol must be in the post-menopausal range and obtained within 28 days prior to registration) OR \r\n* Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable AND FSH values consistent with the institutional normal values for the post-menopausal state; FSH levels must be obtained within 28 days prior to registrationXx_NEWLINE_xXPostmenopausal; use of luteinizing hormone-releasing hormone (LHRH) agonist permittedXx_NEWLINE_xXPatient is postmenopausal.Xx_NEWLINE_xXPremenopausal or postmenopausal womenXx_NEWLINE_xXPregnant (Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.Xx_NEWLINE_xXFemale subjects of childbearing potential must adhere to contraception guidelines as outlined in the protocol. Female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for more than 2 years with a screening serum follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal femalesXx_NEWLINE_xXHave postmenopausal status.Xx_NEWLINE_xXPostmenopausal statusXx_NEWLINE_xXPositive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feedingXx_NEWLINE_xXPostmenopausal status.Xx_NEWLINE_xXPost-menopausal at enrollment (age >= 60, age =< 60 and amenorrhea for >= 12 months in the absence of chemotherapy, tamoxifen, ovarian suppression and follicle stimulating hormone [FSH]/estradiol in the post-menopausal range)Xx_NEWLINE_xXBe of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to screening, or documented surgically sterileXx_NEWLINE_xXpost-menopausal (defined as at least 1 year without any menses) prior to Screening,Xx_NEWLINE_xXPostmenopausal for at least 1 year ORXx_NEWLINE_xXAre post-menopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, ORXx_NEWLINE_xXWomen of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal; postmenopausal is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause OR\r\n* A documented serum follicle-stimulating hormone (FSH) level > 35 mIU/mL (for women with irregular menstrual periods and on hormone replacement therapy)Xx_NEWLINE_xXPatients must be postmenopausal women; for the purposes of this trial, postmenopausal will be defined as:\r\n* Age greater than or equal to 55 years and amenorrheic for 12 or more months; OR\r\n* Age less than 55 years and amenorrheic for 12 or more months in the ABSCENCE of treatment with an intervening agent expected to cause menstrual dysregulation (including but not limited to chemotherapy, tamoxifen, toremifene or ovarian suppression); a documented serum follicular stimulating hormone (FSH) level and serum estradiol level consistent with postmenopausal status as per the institutional normal limits is also required' OR\r\n* Documented bilateral salpingo-oophorectomy regardless of ageXx_NEWLINE_xXBaseline serum FSH, luteinizing hormone LH, and estradiol levels should be drawnXx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXHave been postmenopausal for ?1 yearXx_NEWLINE_xXWomen of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:\r\n* Amenorrhea >= 12 consecutive months without another cause, or\r\n* For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mLXx_NEWLINE_xXSubjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40 pg/mL (< 140 pmol/L); subjects must discontinue HRT prior to study enrollment; for most forms of HRT, at least 2-4 weeks must elapse between the cessation of HRT and determination of menopausal status; length of this interval depends on the type and dosage of HRT; if a female subject is determined not to be post-menopausal, they must use adequate contraceptionXx_NEWLINE_xXNon-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods stated in the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least two to four weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.Xx_NEWLINE_xXWomen of child bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception; women of childbearing potential (WOCBP) receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational product; a WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLXx_NEWLINE_xXPostmenopausal (defined as at least 1 year without any menses) prior to screening, orXx_NEWLINE_xXWomen are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago; for women with therapy-induced amenorrhea, oophorectomy or serial measurements of follicle-stimulating hormone (FSH) and/or estradiol are needed to ensure postmenopausal status; NOTE: ovarian radiation or treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppressionXx_NEWLINE_xXPatients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:\r\n* >= 60 years of age; or\r\n* < 60 years of age and amenorrheic for >= 12 months prior to day 1 if uterus/ovaries are intact; or\r\n* < 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone [FSH] and estradiol within institutional standard for postmenopausal status); or\r\n* < 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or\r\n* < 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or\r\n* Prior radiation castration with amenorrhea for at least 6 monthsXx_NEWLINE_xXPost-menopausal as defined by at least ONE of the following:\r\n* 12 months (365 days) without a period;\r\n* Bilateral oophorectomy;\r\n* Chemically induced menopause as long as there are no plans to stop during the study;\r\n* For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (> 30 mIU/mL) and estradiol in menopausal range per institution’s laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); (Note: women 58 and older do not have to have hormonal tests)\r\n* At least one ovary intact, with a uterus, and 180 days without a period with FSH (> 30 mIU/mL) and estradiol in menopausal range per institution’s laboratory (generally that is < 10 for ultra sensitive assay: < 25-30 otherwise) (Note: women 58 and older do not have to have hormonal tests)Xx_NEWLINE_xXPatients must be pre-menopausal patients within the reproductive age rangeXx_NEWLINE_xXPlease note, pre-menopausal will be defined as women meeting the following criteria:\r\n* Patients not currently on hormonal contraception with the presence of menses in the past 6 months\r\n* If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23 mlU/mL\r\n* If age < 47 years and on hormonal contraception then patient will be eligible regardless of menstrual history\r\n* If age >= 47 years and on hormonal contraception then FSH confirmed < 23 mIU/mLXx_NEWLINE_xXAre postmenopausal for at least 1 year before the screening visit, orXx_NEWLINE_xXPost-menopausal (defined as [A] amenorrhea persisting for an entire year, [B] oophorectomy, or [C] hysterectomy and age greater than 51 years)Xx_NEWLINE_xXPost-menopausal status, as defined by institutional guidelines; concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowedXx_NEWLINE_xXPostmenopausal women, defined by lack of a menstrual period for an entire yearXx_NEWLINE_xXBoth pre- and postmenopausal women will be included in this study; postmenopausal status will be defined as the absence of menses for > 12 months, serum follicle-stimulating hormone (FSH) > 20 mIU/ml, or history of bilateral oophorectomyXx_NEWLINE_xXAll women will be postmenopausal, defined as having follicle-stimulating hormone (FSH) and estradiol within the institutional postmenopausal range at the time of study entry and no menstrual cycle in the last 12 monthsXx_NEWLINE_xXPost-menopausal women defined as either \r\n* At least 2 years without menstrual period or \r\n* Patients at least 50 years or older with serological evidence of post-menopausal status or \r\n* Hysterectomized patients of any age with follicle stimulating hormone (FSH) confirmation of post-menopausal statusXx_NEWLINE_xXBe post-menopausal as defined by any of the following: age > 55 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and follicle-stimulating hormone (FSH) concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomyXx_NEWLINE_xXOvarian insufficiency defined as an elevated follicle-stimulating hormone (FSH) over 10Xx_NEWLINE_xXPost-menopausal, defined as:\r\n* Age >= 45 with no menses for at least 2 years\r\n* Chemically induced menopause through ovarian suppression, as determined by the primary oncologistXx_NEWLINE_xXPostmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal rangeXx_NEWLINE_xXWomen who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea >= 12 monthsXx_NEWLINE_xXPatients must be post-menopausal, as defined by at least one of the following:\r\n* >= 12 months since the last menstrual period OR\r\n* Prior bilateral oophorectomy OR\r\n* Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND (unless >= 60 years of age) follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the postmenopausal stateXx_NEWLINE_xXEligible women are those who:\r\n* Are post-menopausal, verified by:\r\n** Post bilateral surgical oophorectomy; or\r\n** No spontaneous menses >= 1 year; or\r\n** No menses for < 1 year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standardsXx_NEWLINE_xXWomen of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least 23 weeks following the last dose of study treatment (5 half-lives of study drug plus 30 days duration of ovulatory cycle)\r\n* WOCBP are defined as those who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal; post-menopausal is defined as:\r\n** Amenorrhea >= 12 consecutive months without another cause, or\r\n** For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mLXx_NEWLINE_xXWomen of non-child bearing potential must be:\r\n* Women more than 50 years must be post-menopausal for at least 12 months following the end of all exogenous hormonal treatments OR\r\n* Women under 50 years must be postmenopausal for at least 12 months following the end of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution OR\r\n* Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligationXx_NEWLINE_xXNegative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than or equal to (<=) 12 months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) 12 months.Xx_NEWLINE_xXPatients must be postmenopausal, as defined by at least one of the following:\r\n* >= 12 months since the last menstrual period OR\r\n* Prior bilateral oophorectomy OR\r\n* Current use of a GnRH agonist OR\r\n* Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND FSH values consistent with the institutional normal values for the postmenopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registrationXx_NEWLINE_xXPostmenopausal (confirmed by self-report on the Health History Questionnaire; menopausal status could also be confirmed by a recent [< 6 months from enrollment] laboratory report documenting serum follicle-stimulating hormone [FSH] > 30 mIU/ml and/or serum estradiol < 30 pg/ml)Xx_NEWLINE_xXWomen over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptomsXx_NEWLINE_xXPostmenopausal as defined by 1) no menstrual period in the past 12 months; 2) no menstrual period in the past 6 months and an FSH level greater than 40; or 3) women who have had a bilateral oophorectomyXx_NEWLINE_xXPostmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafterXx_NEWLINE_xXPre-menopausal women as defined as four menstrual cycles within the last six months prior to pre-registration; women with less than 4 menses within 6 months prior to pre-registration, or women who have had a hysterectomy with ovaries intact will be considered premenopausal if follicle-stimulating hormone (FSH) level is < 20; women who are using hormonal contraceptives that cause amenorrhea (e.g. injectable and extended oral contraceptives, hormone containing contraceptive ring, or hormone containing intrauterine device) will be considered eligible if they had a minimum of 4 menstrual cycles within the last six months prior to starting on the contraceptiveXx_NEWLINE_xXPremenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2, or EPCAM; (please note: menopause is defined as >= 12 months of amenorrhea; however, for those patients with >= 12 months of amenorrhea who may be pre-menopausal, levels of follicle-stimulating hormone [FSH], luteinizing hormone [LH], and estradiol in the pre-menopausal range will be acceptable)Xx_NEWLINE_xXPostmenopausal women (postmenopausal: age >= 60 years, or amenorrhea >= 12 months, or bilateral oophorectomy, or - in women with hysterectomy only - follicle stimulating hormone [FSH] in the menopausal levels as per local institutional guidelines if < 60 years old) with histologically-confirmed estrogen receptor (ER)-positive (>= 10%) primary breast cancer stage cT0-2, cN0-1, Mx; women with larger tumors who refuse chemotherapy (chemo) and/or endocrine neoadjuvant therapy can be eligibleXx_NEWLINE_xXWomen must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiolXx_NEWLINE_xXPostmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potentialXx_NEWLINE_xXPostmenopausal women (defined per provider discretion and notated in the medical record)Xx_NEWLINE_xXPatients who are post-menopausal (defined as 12 consecutive months without a menstrual period)Xx_NEWLINE_xXWomen with vasomotor symptoms with a uterus who are postmenopausal (no menstrual period for 12 months) or in late menopause transition (no period for 3 months and elevated follicle stimulating hormone [FSH])Xx_NEWLINE_xXPostmenopausal women defined as:\r\n* Prior bilateral oophorectomy \r\n* Age >= 60\r\n* Age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range for the local laboratoryXx_NEWLINE_xXPostmenopausal women, defined as:\r\n* Age > 45 with no menses for at least 2 yearsXx_NEWLINE_xXParticipants must be premenopausal (defined as < 3 months since last menstrual period OR serum follicle-stimulating hormone [FSH] < 20 mIU/mL)Xx_NEWLINE_xXThe study will be conducted in postmenopausal womenXx_NEWLINE_xXPostmenopausal, defined as meeting any of the following criteria: \r\n* Periods stopped more than 6 months ago \r\n* Bilateral oophorectomy \r\n* Not already classified as pre- or peri-menopausal \r\n* Started using hormone therapy for menopausal symptoms before periods stopped, and/or \r\n* Hysterectomy before age 56 years but aged 56 years or more at baselineXx_NEWLINE_xXCurrently taking postmenopausal hormone replacement therapyXx_NEWLINE_xXSubjects must fit into ONE of the following menopausal categories:\r\n* Premenopausal (n = 40) – defined as meeting all the following criteria:\r\n** Have had at least 8 menstrual cycles in the past 12 months\r\n** Have had no hormonal contraception in the past 3 months prior to registration\r\n** Have serum hormone parameters (estradiol [E2], progesterone, follicle stimulating hormone [FSH]) in premenopausal range on the day of random fine needle aspiration (rFNA); NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will occur after registration as part of pre-intervention procedures; if there is mis-assignment of status, the recruitment of future subjects will be adjusted accordingly\r\n* Postmenopausal (n = 40) – defined as meeting all of the following criteria:\r\n** Last menstrual period (LMP) > 1 year previously\r\n** Have had no hormone use in the past 3 months prior to registration\r\n** Serum E2, progesterone, FSH in postmenopausal range on the day of rFNA; NOTE: subjects will self-report menopausal status at registration, and confirmation of hormonal parameters will occur after registration as part of pre-intervention procedures; if there is mis-assignment of status, the recruitment of future subjects will be adjusted accordinglyXx_NEWLINE_xXDocumentation of menopausal status: postmenopausal subjects or pre-menopausal subjects with ovarian radiation or concomitant therapy with a luteinizing hormone-releasing hormone (LH-RH) agonist/antagonist are eligible.Xx_NEWLINE_xXFemale patients must either be: post-menopausal women as defined by a) age >= 60 years of age; b) prior bilateral oophorectomy; c) age < 60 with at least 12 months of spontaneous amenorrhea or post-menopausal range follicle stimulating hormone (FSH) and estradiol levels or premenopausal women receiving a gonadotropin-releasing hormone agonistXx_NEWLINE_xXWomen of childbearing potential must have a negative urine or serum pregnancy test within 28 days of initial dose of olaparib and temozolomide, confirmed prior to treatment on day 1; postmenopausal is defined as:\r\n* Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\r\n* Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for women under 50\r\n* Radiation-induced oophorectomy with last menses > 1 year ago\r\n* Chemotherapy-induced menopause with > 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)Xx_NEWLINE_xXEvidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients; women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply: \r\n* Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\r\n* Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)Xx_NEWLINE_xXPre- and postmenopausal women are eligible; premenopausal women must have a negative serum or urine pregnancy test; pregnancy testing does not need to be pursued in female patients who are: age >= 60 years; or age < 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligationXx_NEWLINE_xXPostmenopausal women\r\n* Amenorrhea for at least 12 months (preceding the time of registration), or\r\n* History of hysterectomy and bilateral salpingo-oophorectomy, or\r\n* At least 55 years of age with prior hysterectomy with or without oophorectomy, or \r\n* Age 35 to 54 with a prior hysterectomy without oophorectomy or with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal rangeXx_NEWLINE_xXPostmenopausal womenXx_NEWLINE_xXPregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapyXx_NEWLINE_xXPatients must be post-menopausal women; post-menopausal women are defined as: (1) those >= 50 years of age who had not menstruated during the preceding 12 months or who had castrate follicle-stimulating hormone levels (> 40IU/L), (2) those who had undergone a bilateral oophorectomyXx_NEWLINE_xXMenopause as defined as no menses for 1 year and/or follicle-stimulating hormone (FSH) >= 25.8 mIU/mlXx_NEWLINE_xXPost-menopausal at time of diagnosisXx_NEWLINE_xXDISEASE CHARACTERISTICS:\n\n          -  Confirmed diagnosis of prior operable, noninflammatory breast cancer meeting the\n             following criteria:\n\n               -  Steroid hormone receptor-positive tumors (estrogen receptor and/or progesterone\n                  receptor), determined by immunohistochemistry, after primary surgery and before\n                  commencement of prior endocrine therapy\n\n               -  Prior local treatment including surgery with or without radiotherapy for primary\n                  breast cancer with no known clinical residual loco-regional disease\n\n               -  Following primary surgery, eligible patients must have had evidence of lymph node\n                  involvement either in the axillary or internal mammary nodes, but not\n                  supraclavicular nodes\n\n               -  Clinically disease-free\n\n          -  Must have completed 4-6 years of prior adjuvant selective estrogen receptor modulators\n             (SERMs), aromatase inhibitors (AIs), or a sequential combination of both\n\n               -  When calculating 4-6 years, neoadjuvant endocrine therapy should not be included\n\n          -  No evidence of recurrent disease or distant metastatic disease\n\n          -  No prior bilateral breast cancer\n\n        PATIENT CHARACTERISTICS:\n\n          -  Female\n\n          -  Must be postmenopausal by any of the following criteria:\n\n               -  Patients of any age who have had a bilateral oophorectomy (including radiation\n                  castration AND amenorrheic for > 3 months)\n\n               -  Patients 56 years old or older with any evidence of ovarian function must have\n                  biochemical evidence of definite postmenopausal status (defined as estradiol,\n                  luteinizing hormone [LH], and follicle-stimulating hormone [FSH] in the\n                  postmenopausal range)\n\n               -  Patients 55 years old or younger must have biochemical evidence of definite\n                  postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal\n                  range)\n\n                    -  Patients who have received prior luteinizing-hormone releasing-hormone\n                       (LHRH) analogues within the last year are eligible if they have definite\n                       evidence of postmenopausal status as defined above\n\n          -  Clinically adequate hepatic function\n\n          -  No bone fracture due to osteoporosis at any time during the 4-6 years of prior therapy\n\n          -  No prior or current malignancy except adequately treated basal cell or squamous cell\n             carcinoma of the skin, in situ carcinoma of the cervix or bladder, or contra- or\n             ipsilateral in situ breast carcinoma\n\n          -  No other nonmalignant systemic diseases (cardiovascular, renal, lung, etc.) that would\n             prevent prolonged follow-up\n\n          -  No psychiatric, addictive, or any other disorder that compromises compliance with\n             protocol requirements\n\n        PRIOR CONCURRENT THERAPY:\n\n          -  See Disease Characteristics\n\n          -  More than 12 months since prior and no other concurrent endocrine SERM/AI therapy\n\n          -  Any type of prior adjuvant therapy allowed including, but not limited to, any of the\n             following:\n\n               -  Neoadjuvant chemotherapy\n\n               -  Neoadjuvant endocrine therapy\n\n               -  Adjuvant chemotherapy\n\n               -  Trastuzumab (Herceptin®)\n\n               -  Ovarian ablation\n\n               -  Gonadotropin releasing hormone analogues\n\n               -  Lapatinib ditosylate\n\n          -  No concurrent hormone-replacement therapy, bisphosphonates (except for treatment of\n             bone loss), or any other investigational agentXx_NEWLINE_xXPostmenopausal women. Postmenopausal status is defined either by:Xx_NEWLINE_xXPatients must be either post-menopausal or surgically post-menopausalXx_NEWLINE_xXSubject is a pregnant or nursing female; exclude the possibility of pregnancy:\r\n* By testing (serum or urine betaHCG) within 24 hours before contrast agent administration, or\r\n* By surgical sterilization, or\r\n* Post-menopausal, with minimum one (1) year history without mensesXx_NEWLINE_xXPatient must be postmenopausal defined as meeting one or more of the following:\r\n* Age >= 60 years\r\n* Amenorrheic for at least 12 months\r\n* Surgically sterile - having undergone bilateral oophorectomy\r\n* Follicle stimulating hormone (FSH) laboratory test level in postmenopausal range according to institutional standards (Note: FSH lab test must be ordered as standard of care to determine best treatment option and should not be ordered simply to confirm eligibility to this study)\r\n* OR pre-menopausal for whom standard ET is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)Xx_NEWLINE_xXconfirming the subject is post menopausal, with a minimum 1 year without mensesXx_NEWLINE_xXFor patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and/or uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment; hormone based oral contraceptives are not allowed on study; postmenopausal is defined as:\r\n* Age >= 60 years\r\n* Age =< 60 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal rangeXx_NEWLINE_xXFemale patients must be willing to use 2 forms of highly effective contraception (per institution standards) from the time of screening until four weeks after discontinuing study, must not be breast feeding, and must have a negative pregnancy test prior to start of dosing if of child bearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: (1) post-menopausal women, defined as either women aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments, or (2) women under 50 years old who have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution; alternatively, women must have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation; male patients should either be surgically sterile or willing to use an effective barrier method of contraception during the study and for 16 weeks following the last dose of study treatment if sexually active with a female of childbearing potential; if not done previously, storage of sperm prior to receiving AZD2014 will be advised to male patients with a desire to have childrenXx_NEWLINE_xXPostmenopausal (defined as at least 1 year without any menses) prior to screening, orXx_NEWLINE_xXHave menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as\r\n* A prior documented bilateral oophorectomy, or\r\n* A history of at least 12 months without spontaneous menstrual bleeding, or\r\n* Age 60 or older with a prior hysterectomy without oophorectomy, or \r\n* Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the labXx_NEWLINE_xXPatient is postmenopausal\r\nFor study purposes, postmenopausal is defined as:\r\n* Age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or\r\n* Age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g. spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or\r\n* Documented bilateral oophorectomyXx_NEWLINE_xXPostmenopausal (no menstrual cycle in the past 12 months)Xx_NEWLINE_xXParticipant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged >= 55 yearsXx_NEWLINE_xXPostmenopausal women defined as women with:Xx_NEWLINE_xXMedically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least 12 consecutive months or follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol blood levels in their respective postmenopausal ranges.Xx_NEWLINE_xXPremenopausal women will be considered eligible for study participation if they are receiving medical ovarian suppression with luteinizing hormone-releasing hormone (LHRH) agonists with documented estradiol blood levels in their respective postmenopausal ranges.Xx_NEWLINE_xXAre postmenopausal for at least 1 year before the Screening visit, orXx_NEWLINE_xXWomen must be postmenopausal (defined as no menstrual cycle for 12 months or surgical history of bilateral salpingoopherectomy); postmenopausal women of all races and ethnic groups are eligible to participate for this trial; men are not eligible\r\n* Note: women who have had a hysterectomy without a bilateral salpingoopherectomy may still be pre-menopausal; confirmation of postmenopausal status is required for these patients and will be measured by testing levels of estradiol, progesterone and follicle stimulating hormone (FSH) (lab ranges per institutional standards); in addition, confirmation of postmenopausal status may be performed in any patient with unclear menopausal status per treating physician discretionXx_NEWLINE_xX