NCT06050109

The Benefits of Continued Use of Ovarian Function Suppression After 5 Years

A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Hongmei Zheng, PhD · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS. This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.

Conditions

• Breast Cancer Female
• Endocrine Therapy

Interventions

Type	Name	Description
DRUG	OFS continues to use group after 5 years use	Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.
DIAGNOSTIC_TEST	Immunohistochemical detection of HR status	Enrolled patients must be HR-positive premenopausal breast cancer patients

Timeline

• Start date: 2023-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-09-22
• Last updated: 2025-03-17

Locations

1 site across 1 country: China