The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
NCT06050109 · Phase II · Wuhan, Hubei, China
- Condition
- Ovarian Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- DRUG, DIAGNOSTIC_TEST
- Intervention
- OFS continues to use group after 5 years use
- Age
- 18 Years to 60 Years
- Gender
- Female
- Sponsor
- Hongmei Zheng, PhD
- Research institution
- Hongmei Zheng, PhD
- Facility
- Wu Xinhong
- Research center
- Wu Xinhong
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.
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 outcomes
invasive disease-free survival
Secondary outcomes
Overall survival