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Recruiting Phase 4 NCT05333328
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Trial Parameters
Condition Breast Cancer
Sponsor Gangnam Severance Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 418
Sex FEMALE
Min Age 20 Years
Max Age 50 Years
Start Date 2023-02-06
Completion 2031-01
All Conditions
Interventions
Ovarian function suppression with endocrine treatments
Brief Summary
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®). In these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.
Eligibility Criteria
Inclusion Criteria: * ER+HER2- breast cancer * Premenopausal and age \<=50 * T1 or T2 * N1 including micrometastasis * Genomic Low Risk by OncoFREE test® (1-20) Exclusion Criteria: * Postmenopausal women * ER-negative breast cancer
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