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

Recruiting now

Conditions studied: Breast Cancer Female, Endocrine Therapy

In brief

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.

Key facts

Study ID: NCT06050109
Run by: Hongmei Zheng, PhD
People needed: 1200
Starts: 2023-09-01
Expected to finish: 2028-09-01
Last updated by the study team: 2025-03-17

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Wu Xinhong — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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