The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OFS continues to use group after 5 years use, Immunohistochemical detection of HR status.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Endocrine Therapy. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years
Overview
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.
Interventions
- Drug OFS continues to use group after 5 years use
Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use. - Diagnostic test Immunohistochemical detection of HR status
Enrolled patients must be HR-positive premenopausal breast cancer patients
Primary outcome measures
- invasive disease-free survival [Time frame: 5 years]
Secondary outcome measures (1)
- Overall survival [Time frame: 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Wu Xinhong — Wuhan
Identifiers
NCT: NCT06050109 · HBCHBCC001