AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer

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Conditions studied: Breast Cancer, Perimenopause, Ovarian Reserve

In brief

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. The goal is to develop a clinically applicable tool to guide endocrine therapy decisions-including the duration of ovarian function suppression (OFS), choice between tamoxifen and aromatase inhibitors (AIs), and selection of CDK4/6 inhibitors-as well as to provide individualized fertility preservation counseling for perimenopausal breast cancer patients.

Key facts

Study ID

NCT07497191

Run by

Shengjing Hospital

People needed

300

Starts

2026-03-05

Expected to finish

2030-03-05

Last updated by the study team

2026-03-27

Who can join

Age: 45 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Use of hormonal intrauterine devices
• Prior use of GnRH agonists or aromatase inhibitors

Full record on ClinicalTrials.gov

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