Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer BRCA Mutations
Sponsor study identifier
observational
609
1 country
8
Study Start
January 2009
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2009
Actual (reported)January 14, 2009
Actual (reported)January 15, 2009
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)
in premenopausal breast cancer patients \& to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.
2 years
To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers.
2 years
To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers.
2 years
To describe the impact of commonly used therapies for early-stage breast cancer on self-reported monthly menstrual cycles and future pregnancy/reproductive health.
2 years
To study the differences in ovarian reserve between BRCA1+ and BRCA2+ women.
2 years
To study sexual health and function in unaffected high risk BRCA mutation carriers
2 years
Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive health questionnaire (Appendix A)/menstrual calendar (Appendix C) / sexual health questionnaires (Appendices E, F, G) ↓ Start planned therapy (or observation) ↓ Evaluation at completion of chemotherapy Blood draw and collection of monthly menstrual calendars ↓ One year post chemo Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) ↓ Annual follow-up x 3 years Blood draw and collection of monthly menstrual calendars/follow-up reproductive health questionnaire (Appendix B) )/ sexual health questionnaires (Appendices E, F, G)
Patients of premenopausal women with early-stage breast cancer will be recruited from the Breast Cancer Service at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell University. In addition, breast cancer patients seeking consultation with a reproductive endocrinologist to address issues of fertility preservation prior to the start of therapy will be offered participation (Dr. Oktay at Yale Medicine. Patients of unaffected high risk premenopausal women with BRCA mutations will be recruited from the Breast Cancer Services especially the high risk surveillance clinics at MSKCC and New York Presbyterian Hospital-Weill Medical College of Cornell Univeristy.
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Oktay KH, Bedoschi G, Goldfarb SB, Taylan E, Titus S, Palomaki GE, Cigler T, Robson M, Dickler MN. Increased chemotherapy-induced ovarian reserve loss in women with germline BRCA mutations due to oocyte deoxyribonucleic acid double strand break repair deficiency. Fertil Steril. 2020 Jun;113(6):1251-1260.e1. doi: 10.1016/j.fertnstert.2020.01.033. Epub 2020 Apr 22.
blood
Shari Goldfarb, MD
Memorial Sloan Kettering Cancer Center
First Submitted
January 14, 2009
First Posted
January 15, 2009
Study Start
January 2009
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Identify eligible premenopausal patients and obtain informed consent ↓ Register patients at Memorial Sloan Kettering Cancer Center ↓ Baseline evaluation: Blood draw and baseline reproductive and sexual health questionnaires (Appendices A, E, F, G)/menstrual calendar (Appendix C) ↓ Year 1 follow up Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G) ↓ Annual follow-up years x 3 if feasible Blood draw and collection of monthly menstrual calendars (Appendix C)/follow-up reproductive and sexual health questionnaires (Appendices B, E, F, G)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
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