NCT07497191Not yet recruiting
AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer
A Clinical Model Based on Dynamic Changes in Anti-Müllerian Hormone to Predict Ovarian Reserve in Perimenopausal Breast Cancer Patients
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 23 Mar 2026
- Start date
- 5 Mar 2026
- Primary completion date
- 5 Mar 2029
- Lead sponsor
- Shengjing Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT07497191
What you commit to
- Study type: Observational
- Planned participants: 300
- From 5 Mar 2026 to the primary completion date, 5 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bilateral oophorectomy or pelvic radiotherapy
- Prior use of GnRH agonists or aromatase inhibitors
Other illness
- 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)
Other
- Postmenopausal status
- Severe hepatic or renal dysfunction
- Current pregnancy, lactation, or planned pregnancy during follow-up
- Use of hormonal intrauterine devices
Who the study is looking for
- 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
Age in the registry: 45 years to 55 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.