The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
NCT ID: NCT06050109
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2023-09-01
2028-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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OFS continues to use after 5 years
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.
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.
Immunohistochemical detection of HR status
Enrolled patients must be HR-positive premenopausal breast cancer patients
OFS discontinues to use after 5 years
The control group did not need to continue to use OFS, either leuprolide or goserelin
No interventions assigned to this group
Interventions
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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.
Immunohistochemical detection of HR status
Enrolled patients must be HR-positive premenopausal breast cancer patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Hongmei Zheng, PhD
OTHER
Responsible Party
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Hongmei Zheng, PhD
vice director
Principal Investigators
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Hongmei Zheng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Wu Xinhong
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBCHBCC001
Identifier Type: -
Identifier Source: org_study_id
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