The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorHongmei Zheng, PhD
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OFS continues to use group after 5 years use
- Immunohistochemical detection of HR status
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hongmei Zheng, PhD
Lead sponsor
Hubei Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov