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Observational Study on Ovarian Reserve in Breast Cancer Patients and BRCA Carriers

This study aims to understand how breast cancer treatments and BRCA gene mutations affect your ovaries. Researchers will look at blood levels of hormones like anti-Mullerian hormone (AMH), estradiol, and follicle stimulating hormone (FSH) before, during, and after cancer treatment. You will also complete questionnaires about your menstrual cycle and overall health. This information will help doctors learn which women might experience early menopause. This study is for women aged 18-44 who are premenopausal and have early-stage breast cancer or a BRCA mutation. The main goal is to see how AMH levels change one year after chemotherapy or hormonal therapy.

Study design
This is an observational study planning to enroll 609 women. It is not a treatment study, but rather aims to gather information.
What's involved
You would have blood draws and complete questionnaires at the start of the study and at follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 2 years, looking at changes in AMH levels one year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00823654

Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations

Recruiting
Not specifiedAges 18–44Observational
Memorial Sloan Kettering Cancer Center
~609 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Blood draw and questionnaires

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)
Measured over 2 years

Conditions

Breast Cancer

Explore related trials

BRCA1 MutationBRCA2 MutationBreast CarcinomaBRCA1 GeneBRCA2 Gene

Where it's being run

8 sites across 2 states
New York5
New Jersey3

Study leadership

  • Shari Goldfarb, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Shari Goldfarb, MD
646-888-5080
Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.
Ovarian resection, unilateral or bilateral oophorectomy, hysterectomy or radiation to pelvic region.
Plans for risk-reducing bilateral oophorectomy within one year of completion of chemotherapy.
Prior known infertility; infertility is defined as one year of inability to conceive despite unprotected intercourse and/or the need to use medication (e.g clomiphene) or assisted reproductive technology (e.g. intrauterine insemination or in vitro fertilization) to attempt pregnancy.
Family history of a first-degree relative with non-surgical menopause \< age 40
Current pregnancy.

What this trial measures

  • characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)2 years

    in premenopausal breast cancer patients \& to characterize the changes in serum AMH from baseline to 1 year in unaffected high risk BRCA mutation carriers.