AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

A Prospective, Observational Clinical Study of AMH Predicting Postchemotherapy Menopause in Premenopausal Breast Cancer Patients Who do Not Use OFS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313476
• Other study ID #: SYSKY-2024-030-01
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the accuracy of AMH postchemotherapy in predicting permanent menopause after chemotherapy in breast cancer patients who did not use OFS before menopause

Description:

For early breast cancer women who are premenopausal, after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy), not using OFS as ovarian suppression, AMH, E2 and FSH levels will be measured by blood sampling before chemotherapy, at the end of chemotherapy and 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after chemotherapy. The menstrual status of patients will be also followed up. At several timing, investigators will analyze AMH level, E2 level, FSH level, proportion of unmeasured AMH (AMH≤0.02ng/ml), proportion of E2 that conforms to menopausal status (E2≤30ng/L), proportion of FSH that conforms to menopausal status (FSH > 30U/L), proportion of persistent amenia (no menstruation from the end of chemotherapy to the evaluation time) and incidence of adverse reactions

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 153
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

Inclusion Criteria:

1. Age over 40(include 40 years old), or before 60, female

2. Primary invasive breast cancer diagnosed by histopathology, except of occult breast cancer, inflammatory breast cancer and Paget's disease

3. Operable patients with no distant metastases at diagnosis (stage T1-T3, any N, M0)

4. The patient was at premenopausal status when first diagnosed (had menstruation in the last 12 months or hormone levels not reached menopause when diagnosed, E2 > 30ng/L, FSH=30U/L)

5. The patient has used chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) after diagnosis

Exclusion Criteria:

1. Age before 40, or over 60(include 60 years old)

2. Patient who accepted bilateral ovariectomy or ovarian radiotherapy

3. Patient who used gonadotropin-releasing hormone agonist ( GnRHa)

4. Stage IV (metastatic) breast cancer

5. The patient was at postmenopausal status when first diagnosed (no menstruation in the past 12 months or hormone levels reached menopause when diagnosed, E2=30ng/L, FSH > 30U/L)

6. The patient has not used chemotherapy (neoadjuvant or adjuvant chemotherapy) since diagnosis

7. The investigator determines that the patient has any other condition that make her unfit to participate in the study

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Mullerian Hormone	Blood Test	Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Secondary	Estradiol	Blood Test	Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Secondary	Follicle Stimulating Hormone	Blood Test	Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy
Secondary	Menstruation	Follow-up	Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy