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Recruiting Observational

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

NCT06050109 · tracked via the Priya Life Science China tracker
Sponsor
Hongmei Zheng, PhD
Phase
Observational
Started
2023-09-01
Last updated
2025-03-17

Condition(s) studied

Breast Cancer FemaleEndocrine Therapy

Investigational drug(s) / intervention(s)

OFS continues to use group after 5 years useImmunohistochemical detection of HR status

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.

Immunohistochemical detection of HR status: Enrolled patients must be HR-positive premenopausal breast cancer patients

Study 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
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • invasive disease-free survival — 5 years
    The main effect evaluation index was invasive disease-free survival (iDFS)

Trial sites (1)

FacilityCityRegionStatus
Wu Xinhong Wuhan Hubei Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06050109 on ClinicalTrials.gov ↗ ← All trials in China