NCT06050109Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1200 (estimated)
- First submitted
- 17 Sept 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Hongmei Zheng, PhD
- NCT number
- NCT06050109
What you commit to
- Study type: Observational
- Planned participants: 1200
- From 1 Sept 2023 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wu Xinhong Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.