AMH Predicts Postchemotherapy Menopause in Premenopausal Breast Cancer Patients

NCT06313476 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2024-030-01
• Study Type: observational
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Anti-Mullerian Hormone

  Blood Test

  Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy

Secondary Outcomes (3)

• Estradiol

  Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy

• Follicle Stimulating Hormone

  Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy

• Menstruation

  Before chemotherapy, within a week after last chemotherapy, 1,3,6,12,18,24 months after chemotherapy

Study Arms (1)

Patients

Premenopausal patients with early breast cancer who received chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) and did not use OFS ovarian suppression at the Breast Cancer Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Premenopausal early breast cancer patients who do not use OFS as ovarian suppression after receiving chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) at the Breast Tumor Center of Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

You may qualify if:

• Age over 40(include 40 years old), or before 60, female
• Primary invasive breast cancer diagnosed by histopathology, except of occult breast cancer, inflammatory breast cancer and Paget's disease
• Operable patients with no distant metastases at diagnosis (stage T1-T3, any N, M0)
• 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)
• The patient has used chemotherapy (neoadjuvant chemotherapy or adjuvant chemotherapy) after diagnosis

You may not qualify if:

• Age before 40, or over 60(include 60 years old)
• Patient who accepted bilateral ovariectomy or ovarian radiotherapy
• Patient who used gonadotropin-releasing hormone agonist ( GnRHa)
• Stage IV (metastatic) breast cancer
• 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)
• The patient has not used chemotherapy (neoadjuvant or adjuvant chemotherapy) since diagnosis
• The investigator determines that the patient has any other condition that make her unfit to participate in the study

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03