RecruitingNCT06050109

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

Sponsor

Hongmei Zheng, PhD

Enrollment

1,200 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Female Endocrine Therapy

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether continuing ovarian function suppression (OFS) — a treatment that temporarily stops the ovaries from producing estrogen — beyond 5 years benefits women with hormone-sensitive early breast cancer. Researchers want to know if extended treatment reduces recurrence risk. **You may be eligible if...** - You have been diagnosed with early-stage, hormone receptor-positive, HER2-negative breast cancer - You are a woman aged 18 to 60 - You have already completed 5 years of OFS treatment - You are in good overall health **You may NOT be eligible if...** - You received less than 5 years of OFS treatment - You have active cancer that has spread to the brain or other organs - You are currently receiving other treatments that interfere with OFS - Your doctor does not think you are a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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