An observational study in Breast Cancer Female and Endocrine Therapy, sponsored by Hongmei Zheng, PhD. Recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Hongmei Zheng, PhD · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hongmei Zheng, PhD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.
Exclusion Criteria:
HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group.
Drug: OFS continues to use group after 5 years use · Diagnostic Test: Immunohistochemical detection of HR status
The control group did not need to continue to use OFS, either leuprolide or goserelin
Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.
Also known as: OFS discontinues to use group after 5 years use
Enrolled patients must be HR-positive premenopausal breast cancer patients
invasive disease-free survival
The main effect evaluation index was invasive disease-free survival (iDFS)
Time frame: 5 years
Overall survival
Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves.
Time frame: 5 years
Quality of life score
Quality of life score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.
Time frame: 5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hongmei Zheng, PhD