Blood Tests to Measure Ovarian Reserves in Women with a BRCA Mutation or Women Treated for Early-Stage Breast Cancer
Clinicaltrials.gov identifier:
NCT00823654
Prevention
Study Contact Information:
For additional information, please contact:
Shari Goldfarb, MD at: 646-888-5080
Kimberly Van Zee, MD at: 646-888-5362
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
About the Study
The purpose of this study is to see how cancer treatment affects the ovaries, such as the impact on conceiving a child or the early onset of menopause. Comparatively, the study will also look at high-risk women with BRCA1/2 mutations (and no evidence of breast or ovarian cancer).
The study will check blood levels of hormones that the ovaries produce and will use questionnaires to gather information about participant menstrual cycles, health, and pregnancies.
What the Study Entails
The study will enroll two groups of participants:
- Premenopausal women with breast cancer
- High-risk women with mutations (and no evidence of breast or ovarian cancer)
Patients in both of the study groups will undergo blood draws, complete questionnaires, and provide monthly menstrual calendars to the study team at intervals for approximately two years.
For the high-risk women with mutations (and no evidence of breast or ovarian cancer), they have an option to participate in annual follow-up for an additional three years.
Study Locations
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Monmouth
Middletown, New Jersey
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Bergen
Montvale, New Jersey
Contact: Shari Goldfarb, MD 646-888-5080
New York
Memorial Sloan Kettering Commack
Commack, New York
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Westchester
Harrison, New York
Contact: Shari Goldfarb, MD 646-888-5080
Memorial Sloan Kettering Cancer Center
New York, New York
Contact: Shari Goldfarb, MD 646-888-5080
Contact: Kimberly Van Zee, MD 646-888-5362
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York
Memorial Sloan Kettering Nassau
Uniondale, New York
Contact: Shari Goldfarb, MD 646-888-5080
For Premenopausal Women with Breast Cancer
- Premenopausal women age 18-44 with 0-III breast cancer, before the start of planned chemotherapy and/or hormonal therapy
- Have regular menstrual cycles
For High-Risk Premenopausal Women with mutation
- Premenopausal Women ages 25-45 with known mutation
- No history of breast or ovarian cancer
- Have regular menstrual cycles
Patients will be excluded if they have:
General
- Prior known infertility
- Family history of a with non-surgical menopause < age 40
- Current pregnancy
Exclusion Criteria: For Premenopausal Women with Breast Cancer
- Had prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or .
- Had an ovarian resection, unilateral or oophorectomy, hysterectomy or radiation to pelvic region.
- Plans for risk-reducing oophorectomy within one year of completion of chemotherapy.
Exclusion Criteria: For High-Risk Premenopausal Women with mutation
- Had prior chemotherapy or for breast cancer or any other cancer
- Had an ovarian resection, unilateral or oophorectomy, hysterectomy, radiation to pelvic region, or ovarian disease (e.g. polycystic ovarian syndrome).
- Plans for risk-reducing oophorectomy within one year