AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer

NCT07497191 | Not Yet Recruiting

• 1 other identifier: LNSZL-LJY02
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer; Perimenopause; Ovarian Reserve

Keywords

Anti-Müllerian Hormone; Ovarian Reserve; Perimenopausal Breast Cancer; Dynamic Monitoring; Predictive Model; Endocrine Therapy; Chemotherapy-Induced Amenorrhea

Outcome Measures

Primary Outcomes (1)

• Association Between Dynamic AMH Changes and Occurrence of Menopause

  The primary outcome is the association between serial changes in anti-Müllerian hormone (AMH) levels measured at seven time points and the occurrence of menopause, defined as 12 consecutive months of amenorrhea in the absence of other causes.

  Up to 36 months

Secondary Outcomes (3)

• Resumption of Menstrual Bleeding After Treatment

  Up to 36 months

• Changes in FSH, E2, and LH Levels

  Up to 36 months

• Menopausal Symptom Score

  Up to 36 months

Study Arms (3)

Group A

Chemotherapy

Group B

Endocrine Therapy

Group C

Targeted Therapy

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll approximately 300 perimenopausal women aged 45-55 years with histologically confirmed hormone receptor-positive breast cancer treated at Liaoning Cancer Hospital. Participants will be stratified into three groups based on treatment regimen: chemotherapy plus endocrine therapy (Group A), chemotherapy plus targeted therapy plus endocrine therapy (Group B), and endocrine therapy alone (Group C). All participants must meet perimenopausal status criteria defined by menstrual history and hormone levels (FSH 10-40 IU/L, E2 \>20 pg/mL) at enrollment.

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

Sponsors & Collaborators

• Shengjing Hospital: lead

Related Publications (3)

• Renee Franklin C, Tanner EJ 3rd. Where Are We Going with Sentinel Lymph Node Mapping in Gynecologic Cancers? Curr Oncol Rep. 2018 Nov 13;20(12):96. doi: 10.1007/s11912-018-0744-4.

  PMID: 30421035 BACKGROUND

• van Zwol-Janssens C, van M Rosmalen M, Laven JSE, Nasserinejad K, Visser JA, Anderson RA, Ben-Aharon I, Freour T, Ruddy KJ, Su HI, Louwers YV, Jager A. AMH as a marker for resumption of ovarian function after chemotherapy: an IPD meta-analysis and systematic review. Cancer Treat Rev. 2026 Jan;142:103068. doi: 10.1016/j.ctrv.2025.103068. Epub 2025 Dec 16.

  PMID: 41447777 BACKGROUND

• Unal C, Ordu C, Ozmen T, Ilgun AS, Celebi F, Baysal B, Ozkurt E, Duymaz T, Erdogan Iyigun Z, Kurt S, Ozturk MA, Pilanci KN, Alco G, Yararbas K, Kayan Tapan T, Guven DC, Soybir G, Ozmen V. Evaluation of Anti-Mullerian Hormone Levels, Antral Follicle Counts, and Mean Ovarian Volumes in Chemotherapy-Induced Amenorrhea among Breast Cancer Patients: A Prospective Clinical Study. Curr Oncol. 2023 Oct 19;30(10):9217-9229. doi: 10.3390/curroncol30100666.

  PMID: 37887566 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jianyi Li, MD

CONTACT

13390127607; lnbreast@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 5, 2029
• Study Completion (Estimated): March 5, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share