All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had: \r\n* A hysterectomy \r\n* A bilateral oophorectomy (ovariectomy) \r\n* A bilateral tubal ligation \r\n* Is post-menopausal
Permanent sterilization (hysterectomy and/or bilateral oophorectomy, or bilateral tubal ligation with surgery, or vasectomy) at least 6 months prior to Screening
Surgically sterile defined as a bilateral tubal ligation at least 6 months prior to administration of study drug, bilateral oophorectomy, or complete hysterectomy, OR
Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy
Prior bilateral oophorectomy;
bilateral tubal occlusion
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not by tubal ligation.
For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
Female 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)
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.
Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); or
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; male 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.
Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); or
Serum or urine pregnancy test must be negative in women judged premenopausal within 7 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization; pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Note: 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.
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy
Bilateral tubal occlusion
All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy
For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
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
A female is eligible to enter and participate in this study if she is of:\r\n* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n** A hysterectomy\r\n** A bilateral oophorectomy (ovariectomy)\r\n** A bilateral tubal ligation\r\n** Is post-menopausal
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, this applies only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
Surgically sterile defined as bilateral tubal ligation or bilateral oophorectomy or hysterectomy
In order to be considered as sterilized or infertile, a patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and bilateral ovariectomy) or be postmenopausal (12 months or more with no period prior to enrolment).
Status after bilateral oophorectomy ( 28 days prior to first study treatment) Inclusion Criteria unique to the AR+ve, TNBC cohort:
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.
Prior bilateral oophorectomy or
bilateral tubal occlusion
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total 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
has not undergone a hysterectomy or bilateral oophorectomy or
Post hysterectomy, bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation at least 6 weeks prior to screening. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure otherwise the subject must be willing to use two adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study therapy. Information must be captured appropriately within the site's source documents
Age ? 18 with prior bilateral oophorectomy
Prior bilateral oophorectomy
Postmenopausal 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)
Has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy); and
Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
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 >= 60 years; or\r\n* Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\r\n* Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
Prior bilateral oophorectomy
Endometrial cancer patients must have underwent surgical treatment (total abdominal hysterectomy/bilateral salpingo oophorectomy [TAH/BSO]) and radiation therapy (EBRT or IVRT)
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 and documented by follow up hormone level assessment
All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy
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 > 60 years; or\r\n* Age < 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\r\n* Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation
bilateral tubal occlusion
Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Or, if of childbearing potential,
Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy), total 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.
Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of therapy.
Surgical sterilization (hysterectomy and/or bilateral oophorectomy) or tubal ligation at least six weeks before start of study treatment.
Have a negative pregnancy test for females at screening, preferably done within 1 week before day 1 of treatment (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:\r\n* A hysterectomy\r\n* A bilateral oophorectomy (ovariectomy)\r\n* A bilateral tubal ligation\r\n* Is post-menopausal
Patients must not have had a prior hysterectomy, bilateral oophorectomy or sterilization of any method
History of hysterectomy, bilateral oophorectomy or ovarian irradiation
Patients 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 state
Negative pregnancy test; women of childbearing potential (not having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > 1 year) must agree to use documented reliable method(s) of contraception; men should agree to use condoms during the study period
Patients 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 registration
Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation)
For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
12 months without a period/menstrual cycle or having had a bilateral oophorectomy.
Participants must be scheduled for risk-reducing salpingo-oophorectomy with or without hysterectomy – either bilateral or unilateral (if prior unilateral oophorectomy or salpingectomy for benign condition)
Postmenopausal 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 range
Surgical menopause with bilateral oophorectomy
Prior bilateral salpingo-oophorectomy
Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer
Prior bilateral surgical oophorectomy, or
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.