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
Hongmei Zheng, PhD
1,200 participants
Sep 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria5
- 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
Interventions
Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.
Enrolled patients must be HR-positive premenopausal breast cancer patients
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06050109