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 early-stage breast cancer
• High-risk women with BRCA 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 BRCA mutations (and no evidence of breast or ovarian cancer), they have an option to participate in annual follow-up for an additional three years.

For Premenopausal Women with Early-Stage Breast Cancer

• Premenopausal women age 18-44 with Stage 0-III breast cancer, before the start of planned chemotherapy and/or hormonal therapy
• Have regular menstrual cycles

For High-Risk Premenopausal Women with BRCA mutation

• Premenopausal Women ages 25-45 with known BRCA 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 first-degree relative with non-surgical menopause < age 40
• Current pregnancy

Exclusion Criteria: For Premenopausal Women with Early-Stage Breast Cancer

• Had prior therapy for breast cancer or any other cancer, such as chemotherapy, hormonal therapy or immunotherapy.
• Had an 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.

Exclusion Criteria: For High-Risk Premenopausal Women with BRCA mutation

• Had prior chemotherapy or immunotherapy for breast cancer or any other cancer
• Had an ovarian resection, unilateral or bilateral oophorectomy, hysterectomy, radiation to pelvic region, or ovarian disease (e.g. polycystic ovarian syndrome).
• Plans for risk-reducing bilateral oophorectomy within one year