Study of Blood Markers to Understand How Treatment Affects Ovarian Health in Premenopausal Women With Early Breast Cancer or BRCA Mutations

What this Trial Is About

Researchers are studying how BRCA gene mutations affect the ovaries in premenopausal women, especially those with early-stage breast cancer or at high genetic risk. The study aims to understand how these mutations may influence fertility and the timing of early menopause by measuring hormone levels and collecting health information over time. Participants will have blood samples taken to measure hormones such as anti-Mullerian hormone AMH, estradiol, and follicle stimulating hormone FSH before, during, and after cancer treatment or observation. They will also complete questionnaires about their menstrual cycles, reproductive health, and sexual function. Follow-ups include monthly menstrual calendars and annual questionnaires for up to three years. During the study, women will attend multiple visits for blood draws and to provide health information. Researchers will monitor changes in hormone levels and menstrual patterns to assess ovarian reserve and reproductive health. The main outcome is to track changes in AMH levels from the start to one year after chemotherapy or hormonal therapy. Safety and health status will be observed throughout, with total participation lasting up to two years or more depending on follow-up.

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