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

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…

ClinicalTrials.gov IDNCT06050109

PhaseNot Applicable

Enrollment1200

SponsorHongmei Zheng, PhD

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Female, Endocrine Therapy

About this study

Interventions

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

Primary outcomes

invasive disease-free survival (5 years)

Eligibility information

Inclusion Criteria: * Diagnosed with early primary breast cancer * Female aged 18-60 years (including 18 year and 60 year) * Hormone receptor (HR) positive HER2 negative * Receive 5 years of OFS treatment * ECOG score 0-1 * Voluntarily join this study and sign the informed consent form; * The researcher believes that it can benefit. Exclusion Criteria: * The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years * Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision * Invasive metastases with known obvious symptoms * Invasive metastases with known obvious symptoms * Doctors think it is not suitable for inclusion

Study locations

Wu Xinhong, Wuhan, Hubei China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.