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NCT07735897
Long Term Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women
Conditions: Breast Cancer
Sex: Female
Ages: 20 Years – 45 Years
Healthy volunteers: No
Enrollment: 1483
Sponsor: MedicalExcellence
Location: Asan Medical Center Seoul Sondpagu
Summary
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. The study will assess recurrence, breast cancer-specific survival, and overall survival beyond 10 years to determine the long-term benefits of OFS treatment.
Eligibility Criteria
Inclusion Criteria:
* Premenopausal women with hormone receptor-positive breast cancer enrolled in the ASTRRA trial (NCT00912548).
Patients enrolled and randomized in the ASTRRA study between March 1, 2009, and July 17, 2018 (excluding screening failures).
Patients with available long-term follow-up information.
Exclusion Criteria:
* Patients with primary breast cancer meeting any of the following criteria:
Hormone receptor-negative breast cancer Unknown hormone receptor status
Patients with a history of hysterectomy or bilateral oophorectomy
Patients with breast sarcoma or squamous cell carcinoma of the breast
Patients with a history of malignancy other than breast cancer within 5 years prior to enrollment
Patients with thrombocytopenia
Patients who had previously received CMF chemotherapy (cyclophosphamide, methotrexate, and fluorouracil)
Source: ClinicalTrials.gov (NCT07735897). StuddyBuddy aggregates publicly available trial information.