Patients must not be pregnant or nursing\r\n* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
Menopausal 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 state
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
ENDOCRINE RESISTANT COHORT: Pre- or post-menopausal women are eligible; if premenopausal, patient must be willing to comply with pregnancy requirements and agrees with GnRH agonist therapy for ovarian suppression during the study
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
Pre- or post-menopausal women are allowed; if pre- or peri-menopausal, concurrent ovarian suppression for pre- or peri-menopausal women is required
Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
ER+ and/or PR+ (Note: This group of patients must have received at least 1 and up to 3 prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER2+ patients in this group must have received a minimum of 2 lines of HER2-directed therapy in the advanced setting.) This group of patients may be pre-menopausal with ovarian suppression or post-menopausal. LHRH agonists maybe used to render ovarian suppression with post-menopausal ranges of estradiol or FSH per institutional guidelines.
Post-menopausal or undergoing ovarian suppression
Postmenopausal, 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 screening
If patient is pre- or peri- menopausal, then will need to have concurrent ovarian suppression; patients may have already gotten the loading dose of ovarian suppression; pre- or peri-menopausal subjects must have a negative urine pregnancy test confirmed at screening
Patients may be pre- or post-menopausal; pre-menopausal patients must be on ovarian suppression and must be adequately suppressed on luteinizing hormone-releasing hormone (LHRH) agonists with estradiol levels in the post-menopausal range\r\n* Premenopausal patients cannot be pregnant and must agree to adequate birth control in addition to ovarian suppression; agreement by the patient and/or partner to use highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception; contraception use should continue during the duration of study treatment and for at least 6 months after the last dose of study treatment
Patients 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 amenorrhea
Women who are pre-menopausal must have a negative serum pregnancy test; subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy
Post- menopausal female patients, 18 years of age or greater.
Positive pregnancy test (for pre-menopausal women)
For Part 2, any menopausal status
Pre/perimenopausal women must be amenable to be treated with goserelin. All patients will be rendered post-menopausal secondary to concomitant administration of goserelin.
Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over 12 months since final menstrual period) must have a negative pregnancy test within 7 days prior to first dose.
Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and for women less than 12 months after the onset of menopause
Post-menopausal
Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
Post-, pre- or peri-menopausal women considered to be in the post?menopausal state as defined by one of the following:
Patients must be post-menopausal women, as defined in the protocol
Any menopausal status
On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
Is not post-menopausal (defined as amenorrhea >12 consecutive months).
Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Premenopausal or peri-menopausal women.
Evidence of post-menopausal status or negative urinary or serum pregnancy test.
Negative serum pregnancy test for female subjects (unless surgically sterile or greater than two years post-menopausal)
Post-menopausal status over 1 year
Study subjects should be post-menopausal women (premenopausal women are eligible if they are on or willing to be on mandatory ovarian function suppression)
Negative serum pregnancy test within <30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause
Women for whom adjuvant treatment with an aromatase inhibitor would be clinically indicated; women must be either post-menopausal, or premenopausal having undergone oophorectomy
Pregnant or lactating women; all pre-menopausal and peri-menopausal women should have a urine test for pregnancy within a week of starting therapy; all patients of child bearing potential should agree to use an effective contraceptive method
Post-menopausal
Negative serum pregnancy test for pre-menopausal women and women within 12 months from the onset of menopause
Negative pregnancy test for pre-menopausal women
of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post- menopausal); or,
Patients must be pre-menopausal patients within the reproductive age range
Post-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 status
Post-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 oncologist
Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
Patients who are pregnant are excluded; pre-menopausal women must have a negative pregnancy test; patients that are post-menopausal, or that have had a hysterectomy do not need to have a pregnancy test
Post-menopausal or negative urine and/or blood pregnancy test
Participants must be pre- or post-menopausal
Patients who are post-menopausal (defined as 12 consecutive months without a menstrual period)
Pregnant 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 chemotherapy
Post-menopausal at time of diagnosis
Patients must be either post-menopausal or surgically post-menopausal
Women who are pre-menopausal must have a negative serum pregnancy test
Subject 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 menses
Women who are pre-menopausal must have a negative serum pregnancy test
Women who are pre-menopausal must have a negative serum pregnancy test
If a female and pre-menopausal, must have a negative pregnancy test.
Pregnancy or breastfeeding; women of childbearing potential must have a negative pregnancy test prior to undergoing MRI/PET imaging; post-menopausal status may be established by patient reported history of absence of menses over the last 12 months
For females: negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
Female patient must have effective contraception throughout the study and must have a negative urine pregnancy test at inclusion, or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea)
For females: negative urine pregnancy test or post-menopausal for at least 2 years or patient has had a hysterectomy