NCT07497191
AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer
Not Yet Recruiting · Not specified · Shengjing Hospital · registry updated 2026-03-27
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study is a prospective observational cohort study aimed at developing a clinical model based on dynamic changes in anti-Müllerian hormone (AMH) to predict ovarian reserve in perimenopausal women with hormone receptor-positive breast cancer. The study will enroll approximately 300 women aged 45-55 years with perimenopausal status confirmed by menstrual history and hormone levels (FSH 10-40 IU/L, E2 \>20 pg/mL). Participants will be stratified by treatment regimen: (A) chemotherapy plus endocrine therapy, (B) chemotherapy plus targeted therapy plus endocrine therapy, and (C) endocrine therapy alone. Blood samples will be collected at seven time points to measure AMH, FSH, E2, and LH. Menstrual patterns and menopausal symptoms will be recorded prospectively. The primary outcome is the association between dynamic AMH changes and the occurrence of menopause. A predictive model will be constructed using LASSO regression and Cox proportional hazards models, with internal validation by bootstrap resampling....
Inclusion
- Female, aged 45-55 years
- Histologically confirmed hormone receptor-positive breast cancer
- Perimenopausal status defined as: (a) last menstrual period within 3 months prior to enrollment; and (b) FSH 10-40 IU/L and E2 \>20 pg/mL
- Scheduled to receive adjuvant chemotherapy and/or endocrine therapy
- Willing to undergo serial blood sampling and complete menstrual diaries
- Able to provide written informed consent
Exclusion
- Postmenopausal status
- Prior bilateral oophorectomy or pelvic radiotherapy
- Severe hepatic or renal dysfunction
- Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative breast cancer
- Conditions affecting ovarian hormone secretion (e.g., ovarian tumors, polycystic ovary syndrome, pituitary tumors)
- Current pregnancy, lactation, or planned pregnancy during follow-up