Postmenopausal, verified by: \r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >=  year or\r\n* No menses for <  year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Pre/peri- and postmenopausal women and all men are eligible for this trial; postmenopausal is defined as:\r\n* Age >=  years and one year or more of amenorrhea\r\n* Age <  years and one year or more of amenorrhea, with estradiol <  pg/ml\r\n* Age <  with prior hysterectomy but intact ovaries, with estradiol <  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  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 trial
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative pregnancy test within  days prior to study registration\r\n* Note: Postmenopausal is defined as one or more of the following:\r\n** Age >=  years\r\n** Age <  years and amenorrheic for at least  year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n** Bilateral oophorectomy
Postmenopausal 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 >=  years\r\n* Age <  and amenorrhea for  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 normal
Cohort B Safety Run-In (Ribociclib + PDR + Fulvestrant): Women must be postmenopausal as defined as:\r\n* Age >  years or\r\n* Age >  with intact uterus and amenorrhea for >=  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  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-surgery
Expansion Cohort B (Ribociclib + PDR + Fulvestrant): Women must be postmenopausal as defined as:\r\n* Age >  years or\r\n* Age >  with intact uterus and amenorrhea for >=  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  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-surgery
Postmenopausal women as defined as:\r\n* Age >  years or\r\n* Age >=  with intact uterus and amenorrhea for >=  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  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-surgery
Post-menopausal (>=  years of age or with follicle stimulating hormone [FSH] >  IU/L if age -)
Only 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**  years of age or older\r\n** Age less than  years; amenorrheic for  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)
INCLUSION - ENROLLMENT: Only postmenopausal women will be eligible. Subjects will be classified as being postmenopausal if they have had:\r\n* No spontaneous menses >  year, or\r\n* Bilateral surgical oophorectomy, or\r\n* No menses for <  year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Postmenopausal 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 >=  years\r\n* Age <  years and  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 oophorectomy
Female 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  years of age; OR\r\n* Subjects under  years of age and naturally (spontaneous, no alternative pathologic or physiological cause) amenorrhea for at least  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  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  days prior to study enrollment
Female subjects will be considered of non-reproductive potential if they are either:\r\n* Postmenopausal (defined as at least  months with no menses without an alternative medical cause; in women <  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  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  weeks prior to screening; OR\r\n* Has a congenital or acquired condition that prevents childbearing
Post-menopausal (if female) defined as: ) prior bilateral oophorectomy, ) age  or over, or ) <  years and amenorrheic for at least  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 study
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through  months after the last dose of talimogene laherparepvec; (note: women not of childbearing potential are defined as: any female who is post-menopausal [age >  years with cessation of menses for  or more months or less than  years but not spontaneous menses for at least  years or less than  years and spontaneous menses within the past  year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels >  IU/L) or postmenopausal estradiol levels (<  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)
Male and female subjects of childbearing potential who are unwilling to use acceptable method(s) of effective contraception during study treatment and through  months after the last dose of talimogene laherparepvec and  months after the last dose of pembrolizumab; (Note: women not of childbearing potential are defined as: any female who is post-menopausal [age >=  years with cessation of menses for  or more months or less than  years but not spontaneous menses for at least  years or less than  years and spontaneous menses within the past  year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels >  IU/L) or postmenopausal estradiol levels (<  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)
Postmenopausal is defined either by age >= , prior bilateral oophorectomy, or age <  with intact uterus and no spontaneous menses over  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 study
Postmenopausal 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 >=  years\r\n** Age <  and amenorrhea for  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  weeks prior to cycle  day  (CD) of anti-estrogen therapy
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within  hours prior to initiating study treatment; Note: postmenopausal is defined as any of the following:\r\n* Age >=  years\r\n* Age <  years and amenorrheic for at least  year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n* Bilateral oophorectomy
Women under  years-of-age would be considered postmenopausal if they have been amenorrhoeic for at least  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.
Postmenopausal status is defined either by: I). Prior bilateral oophorectomy OR ii). Age ?  OR iii). Age <  and amenorrhea for  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 < , 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.
Post-menopausal defined as\r\n* Age >=  and amenorrhea >  consecutive months, OR\r\n* Age <  and amenorrhea >  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 oophorectomy
Women 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  weeks prior to enrollment; NOTE: Postmenopausal status is defined by at least one of the following criteria:\r\n* Age >=  years\r\n* Age <  and cessation of regular menses for at least  consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone (FSH) level within the laboratorys reference range for postmenopausal females\r\n* Documented bilateral oophorectomy; or,\r\n* Medically confirmed ovarian failure
Post-menopausal status defined by: a) age ?  years; b) age <  years and cessation of regular menses for at least  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 start
Post-menopausal defined as\r\n* Age >=  years and  year or more of amenorrhea\r\n* Age <  years and  year or more of amenorrhea with an estradiol assay <  pg/mL\r\n* Surgical menopause with bilateral oophorectomy
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test within  days prior to initiating study treatment; Note: Postmenopausal is defined as one or more of the following:\r\n* Age >=  years\r\n* Age <  years and amenorrheic for at least  year with follicle-stimulating hormone (FSH) and plasma estradiol levels in the postmenopausal range\r\n* Bilateral oophorectomy
Post-menopausal women with clinical stage I-IV, ER positive/HER 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  or greater\r\n* Age is under  but she has had at least  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)
Postmenopausal status, as defined by the National Comprehensive Cancer Network\r\n* Age >  years old OR\r\n* Prior bilateral oophorectomy regardless of age\r\n* If patient <  years old and amenorrheic for >  months or in the absence of ovarian suppression, follicle-stimulating hormone (FSH) and estradiol have to be in the postmenopausal range
Female patients should be either:\r\n* Postmenopausal, as defined by at least one of the following criteria:\r\n* Age >=  years\r\n* Age =<  years and cessation of regular menses for at least  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 start
For 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  days after the last dose of study treatment or  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 >=  years\r\n* Age =<  years and amenorrheic for  months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range
Postmenopausal or premenopausal; \r\n* NOTE: Postmenopausal women, verified by: \r\n** Bilateral surgical oophorectomy, or \r\n** No spontaneous menses >=  year or \r\n** No menses for <  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 standards
Post-menopausal status defined by any of the following:\r\n* Age >  years\r\n* History of bilateral oophorectomy\r\n* Spontaneous amenorrhea for  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  months or previous hysterectomy
Age  years and  year or more of amenorrhea with LH and/or FSH levels in the postmenopausal range
Age  with prior hysterectomy but intact ovaries with LH and/or FSH levels in the postmenopausal range
Prior 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 range
Female 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  months after the last dose of study treatment. (Women of not childbearing potential: post-menopausal [age >  years with cessation of menses >  months or <  years but not spontaneous menses for at least  years or <  years and spontaneous menses within the past  year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels >  IU/L) or postmenopausal estradiol levels (<  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).
Non pregnant: negative serum test for pregnancy, unless male, prior hysterectomy, tubal ligation, or postmenopausal; (Note: postmenopausal is defined as age >  with amenorrhea for >  year or age <  years with amenorrhea for  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)
Age < and amenorrhea for  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 <, 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 status
Post-menopausal subjects as defined by any of the following:\r\n* Subjects at least  years of age\r\n* Subjects under  years of age and amenorrheic for at least  months or follicle-stimulating hormone (FSH) values >=  IU/L and estradiol levels =<  IU/L\r\n* Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least  months
Subject is post-menopausal defined as age over  or status post bilateral oophorectomy; in subjects aged - 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 entry
Women are considered post-menopausal and not of child-bearing potential if they have had  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 suppression
Patients may be premenopausal or postmenopausal at the time of randomization; for study purposes, postmenopausal is defined as:\r\n* Age  or older with no spontaneous menses for at least  months prior to study entry; or\r\n* Age  or younger with no spontaneous menses for at least  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 oophorectomy
Patients must be postmenopausal defined as:\r\n* Age >=  years and one year or more of amenorrhea\r\n* Age <  years and one year or more of amenorrhea, with an estradiol assay <  pg/mL\r\n* Surgical menopause with bilateral oophorectomy (at least  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 allowed
Follicle stimulating hormone measurement elevated into the menopausal range
If letrozole is selected as the control therapy, patients must be postmenopausal, either following bilateral oophorectomy or at least  years after spontaneous menopause; patients within  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 started
Women must be postmenopausal\r\n* Postmenopausal status is verified by:\r\n** Prior bilateral surgical oophorectomy, or\r\n** Age >=  years, or\r\n** Age <  with no menses for >  year with follicle-stimulating hormone (FSH) and estradiol levels within post menopausal range, according to institutional standard
Amenorrheic for >  years without a hysterectomy and oophorectomy and a Follicle Stimulating Hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation
Age < years with amenorrhea for at least  months and both follicle-stimulating hormone (FSH) and estradiol levels are in postmenopausal range (according to the local laboratory)
Age <  years and cessation of regular menses for at least  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 range
Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through  months after the last dose of talimogene laherparepvec; (women of not childbearing potential: post-menopausal [age >  years with cessation of menses >  months or <  years but not spontaneous menses for at least  years or <  years and spontaneous menses within the past  year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels >  IU/L) or postmenopausal estradiol levels (<  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)
Only 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 >  year or\r\n* No menses for <  year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Postmenopausal status, defined as any one of the following criteria:\r\n* Documented history of bilateral oophorectomy\r\n* Age  years or more\r\n* Age  to  and satisfying one or more of the following criteria:\r\n** Amenorrhea for at least  months and intact uterus\r\n** Amenorrhea for less than  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 replacement
Postmenopausal women are eligible; postmenopausal is defined as any of the following:\r\n* Age >=  years\r\n* Age <  and amenorrhea for  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  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 surgery
Patients must be postmenopausal women defined as: Age  or older with no spontaneous menses for at least  months prior to study entry; or Age  or younger with no menses for at least  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  with documented bilateral oophorectomy.
Postmenopausal women (women are considered post-menopausal and not of child-bearing potential if they are >  years of age and have had  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 acceptable
Post-menopausal women, as verified by:\r\n* Post bilateral surgical oophorectomy, or\r\n* No spontaneous menses >=  year, or\r\n* No menses for <  year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Premenopausal patients must have a negative serum or urine pregnancy test; pregnancy testing does not need to be pursued in patients who are:\r\n* Age >=  years; or\r\n* Age <  with intact uterus and amenorrhea for  consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\r\n* Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Age < and amenorrhea for  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.
Postmenopausal 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 >=  years and one year or more of amenorrhea\r\n* Age <  years and one year or more of amenorrhea, with an estradiol assay within the post-menopausal range\r\n* Age <  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-study
Patients 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  years of age; OR\r\n* Subjects under  years of age and naturally (spontaneous) amenorrhea for at least  months or follicle-stimulating hormone (FSH) values >=  IU/L and estradiol levels =<  IU/L; OR\r\n* Prior bilateral oophorectomy; OR\r\n* Prior radiation castration with amenorrhea for at least  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 suppression
Menopausal at study entry as described by: \r\n* Surgical menopause (TAH/BSO), or\r\n* Age >=  years and cessation of menstruation for at least  year, or\r\n* Age <  years and cessation of menstruation for at least  year with estradiol level in post-menopausal range, or\r\n* Rendered post-menopausal with the use of luteinizing hormone-releasing hormone (LHRH) agonist
Postmenopausal women; women are eligible if they are postmenopausal (older than  years of age with no spontaneous menses for at least  months; or  years of age or younger either with no spontaneous menses [amenorrheic] within  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)
Postmenopausal women are eligible; postmenopausal is defined as any of the following:\r\n* Age >  years\r\n* Age >  with intact uterus and amenorrhea for  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  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-surgery
Postmenopausal women defined by one of the criteria:\r\n* No spontaneous menses for at least  months if the subject is >=  years old\r\n* Amenorrheic for at least  months if the subject is <  years old, with serum estradiol within the institutional postmenopausal range\r\n* Bilateral oophorectomy\r\n* If prior hysterectomy but intact ovaries, must be >=  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 range
Female patients must either be: post-menopausal women as defined by a. age >=  years of age; b. prior bilateral oophorectomy; c. age <  with at least  months of spontaneous amenorrhea or post-menopausal range follicle-stimulating hormone (FSH) and estradiol levels OR premenopausal women receiving a gonadotropin-releasing hormone agonist
Premenopausal women must have a negative serum or urine pregnancy test; pregnancy testing does not need to be pursued in female participants who are:\r\n* Age >  years; or\r\n* Age <  with intact uterus and amenorrhea for  consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\r\n* Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Patient is postmenopausal or premenopausal\r\n* NOTE: postmenopausal women, verified by\r\n** Bilateral surgical oophorectomy, or\r\n** No spontaneous menses >=  year or\r\n** No menses for <  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 standards
Women of child-bearing potential (i.e. =<  years of age or has had menstrual cycle within the past  months, if >  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 screening
Reproductive status for cohort : 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 >=  months (if =<  years of age and prior chemotherapy or on medical ovarian ablative therapy or received ovarian radiation for ablation in the past  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  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  days prior to registration
Post-menopausal at enrollment (age >= , age =<  and amenorrhea for >=  months in the absence of chemotherapy, tamoxifen, ovarian suppression and follicle stimulating hormone [FSH]/estradiol in the post-menopausal range)
Patients must be postmenopausal women; for the purposes of this trial, postmenopausal will be defined as:\r\n* Age greater than or equal to  years and amenorrheic for  or more months; OR\r\n* Age less than  years and amenorrheic for  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 age
Baseline serum FSH, luteinizing hormone LH, and estradiol levels should be drawn
Women are considered post-menopausal and not of child-bearing potential if they have had  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 suppression
Patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria:\r\n* >=  years of age; or\r\n* <  years of age and amenorrheic for >=  months prior to day  if uterus/ovaries are intact; or\r\n* <  years of age, and the last menstrual period - months prior to day , 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* <  years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or\r\n* <  years of age and history of bilateral oophorectomy; surgery must have been completed at least  weeks prior to day ; or\r\n* Prior radiation castration with amenorrhea for at least  months
Post-menopausal as defined by at least ONE of the following:\r\n*  months ( 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  and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (>  mIU/mL) and estradiol in menopausal range per institutions laboratory (<  for ultra sensitive assay: < - otherwise); (Note: women  and older do not have to have hormonal tests)\r\n* At least one ovary intact, with a uterus, and  days without a period with FSH (>  mIU/mL) and estradiol in menopausal range per institutions laboratory (generally that is <  for ultra sensitive assay: < - otherwise) (Note: women  and older do not have to have hormonal tests)
Post-menopausal (defined as [A] amenorrhea persisting for an entire year, [B] oophorectomy, or [C] hysterectomy and age greater than  years)
All 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  months
Be post-menopausal as defined by any of the following: age >  years, history of bilateral oophorectomy, amenorrhea for  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  months or previous hysterectomy
Eligible women are those who:\r\n* Are post-menopausal, verified by:\r\n** Post bilateral surgical oophorectomy; or\r\n** No spontaneous menses >=  year; or\r\n** No menses for <  year with follicle stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes: BRCA, BRCA, BRIP, PALB, RADC, RADD, BARD, MSH, MSH, MLH, or PMS, or EPCAM; (please note: menopause is defined as >=  months of amenorrhea; however, for those patients with >=  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)
Postmenopausal women (postmenopausal: age >=  years, or amenorrhea >=  months, or bilateral oophorectomy, or - in women with hysterectomy only - follicle stimulating hormone [FSH] in the menopausal levels as per local institutional guidelines if <  years old) with histologically-confirmed estrogen receptor (ER)-positive (>= %) primary breast cancer stage cT-, cN-, Mx; women with larger tumors who refuse chemotherapy (chemo) and/or endocrine neoadjuvant therapy can be eligible
Women 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 estradiol
Postmenopausal women defined as:\r\n* Prior bilateral oophorectomy \r\n* Age >= \r\n* Age <  and amenorrhea for  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 laboratory
Postmenopausal, defined as meeting any of the following criteria: \r\n* Periods stopped more than  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  years but aged  years or more at baseline
Subjects must fit into ONE of the following menopausal categories:\r\n* Premenopausal (n = )  defined as meeting all the following criteria:\r\n** Have had at least  menstrual cycles in the past  months\r\n** Have had no hormonal contraception in the past  months prior to registration\r\n** Have serum hormone parameters (estradiol [E], 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 = )  defined as meeting all of the following criteria:\r\n** Last menstrual period (LMP) >  year previously\r\n** Have had no hormone use in the past  months prior to registration\r\n** Serum E, 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 accordingly
Female patients must either be: post-menopausal women as defined by a) age >=  years of age; b) prior bilateral oophorectomy; c) age <  with at least  months of spontaneous amenorrhea or post-menopausal range follicle stimulating hormone (FSH) and estradiol levels or premenopausal women receiving a gonadotropin-releasing hormone agonist
Pre- 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 >=  years; or age <  with intact uterus and amenorrhea for  consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Patients must be post-menopausal women; post-menopausal women are defined as: () those >=  years of age who had not menstruated during the preceding  months or who had castrate follicle-stimulating hormone levels (> IU/L), () those who had undergone a bilateral oophorectomy
DISEASE 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 - years of prior adjuvant selective estrogen receptor modulators\n             (SERMs), aromatase inhibitors (AIs), or a sequential combination of both\n\n               -  When calculating - 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 >  months)\n\n               -  Patients  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  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 - 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  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 agent
Patient must be postmenopausal defined as meeting one or more of the following:\r\n* Age >=  years\r\n* Amenorrheic for at least  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)
For 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  days after the last dose of study treatment; hormone based oral contraceptives are not allowed on study; postmenopausal is defined as:\r\n* Age >=  years\r\n* Age =<  years and amenorrheic for  months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range
Have 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  months without spontaneous menstrual bleeding, or\r\n* Age  or older with a prior hysterectomy without oophorectomy, or \r\n* Age less than  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 lab
Patient is postmenopausal\r\nFor study purposes, postmenopausal is defined as:\r\n* Age  or older with no spontaneous menses for at least  months prior to study entry; or\r\n* Age  or younger with no spontaneous menses for at least  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 oophorectomy
Medically confirmed post-menopausal status defined as spontaneous cessation of regular menses for at least  consecutive months or follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol blood levels in their respective postmenopausal ranges.