Evaluating the benefits of continued ovarian function suppression for breast cancer 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
This study is testing if continuing ovarian function suppression for premenopausal women with early hormone receptor positive breast cancer after 5 years helps them stay healthier compared to those who stop the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06050109 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical efficacy and safety of continuing ovarian function suppression (OFS) in premenopausal women diagnosed with early hormone receptor positive, HER2 negative breast cancer after they have completed 5 years of OFS treatment. The study will involve two cohorts: one that continues OFS and another that discontinues it, with data collected from hospital medical records over a three-year period. By comparing outcomes between these groups, the study seeks to provide insights into the long-term benefits of sustained OFS therapy.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18-60 with early hormone receptor positive, HER2 negative breast cancer who have completed 5 years of OFS treatment.
Not a fit: Patients who have not received OFS treatment for at least 5 years or those with significant metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the advantages of prolonged ovarian function suppression in improving outcomes for breast cancer patients.
How similar studies have performed: While the approach of evaluating prolonged OFS is not widely tested, similar studies have shown promising results in hormone receptor positive breast cancer management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wuhan, Hubei
- Wu Xinhong — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Hongmei Zheng, Doctor — Study Principal Investigator
- Study coordinator: Hongmei Zheng, Doctor
- Email: zhenghongmeicj@163.com
- Phone: 18971624606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.