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 weeks before commencing trial therapy; post-menopausal status is defined either by \r\n** Prior bilateral oophorectomy\r\n** Age greater than \r\n** Age less than years with an intact uterus and amenorrhoeic for at last months. \r\n** For patients aged less than years with amenorrhea for less than 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
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
ER+ and/or PR+ (Note: This group of patients must have received at least and up to prior hormonal therapies and at least one prior chemotherapy treatment in the advanced setting. HER+ patients in this group must have received a minimum of lines of HER-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
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
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
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Women who are pre-menopausal must have a negative serum pregnancy test; subjects must agree to use appropriate contraception until weeks after the completion of chemotherapy
Post- menopausal female patients, years of age or greater.
Positive pregnancy test (for pre-menopausal women)
For Part , any menopausal status
Pregnant patients or patients who are breast feeding. Subjects capable of pregnancy (post menarche and not post-menopausal, defined as over months since final menstrual period) must have a negative pregnancy test within days prior to first dose.
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Negative serum pregnancy test within days of enrollment for pre-menopausal women and for women less than 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 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
Is not post-menopausal (defined as amenorrhea > consecutive months).
Female patients must be surgically sterile, post-menopausal (for at least year), or have negative results from a pregnancy test performed as follows:\r\n* At screening, on a serum sample obtained within days prior to the first study drug administration, and\r\n* Prior to dosing, on a urine sample obtained on day of treatment if it has been > days since obtaining the serum pregnancy test result
Adequate organ and marrow function; Evidence of post-menopausal status or negative urinary or serum pregnancy test.
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)
Negative serum or urine pregnancy test; the pregnancy test result must be obtained prior to the first administration of AUY (=< days prior to dosing) in all pre-menopausal women and women < years after the onset of menopause
Post-menopausal status over year
Negative urine or serum pregnancy test in women with childbearing potential (defined as not post-menopausal for months or no previous surgical sterilization), within one week prior to initiation of treatment
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test)
Negative serum pregnancy test within < days of surgery in pre-menopausal women and women < years after the onset of menopause
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test
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
Female subjects must have a negative serum human chorionic gonadotropic (hCG) test (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are > year post-menopausal); and
Pre-menopausal women must have a negative pregnancy test before study entry and agree to use a medically acceptable method of contraception throughout the treatment period and for at least six weeks after treatment discontinuation
Negative serum pregnancy test for pre-menopausal women and women within months from the onset of menopause
Negative pregnancy test for pre-menopausal women
Patients must be pre-menopausal patients within the reproductive age range
Post-menopausal women defined as either \r\n* At least years without menstrual period or \r\n* Patients at least 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
All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
Pre-menopausal women without a negative serum or urine pregnancy test within weeks of starting treatment
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
A positive urine pregnancy test during the screening period. Women who are one year post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test.
Patients who are post-menopausal (defined as consecutive months without a menstrual period)
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test
A positive urine pregnancy test during the screening period; women who are two years post-menopausal, or who have had a tubal ligation or a partial of full hysterectomy will not be subject to a urine pregnancy test
Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test
Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within hours prior to or on study visit # (day ) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following ) prior hysterectomy, ) absence of menstrual period for year in the absence of prior chemotherapy or ) absence of menstrual period for 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 hours before contrast agent administration, or\r\n* By surgical sterilization, or\r\n* Post-menopausal, with minimum one () 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 months
For females: negative serum pregnancy test OR post-menopausal for at least 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 months of amenorrhea)
For females: negative urine pregnancy test or post-menopausal for at least years or patient has had a hysterectomy