Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07661927). This is a study registration, not published results. Lead sponsor: UNICANCER. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 700 participants (ESTIMATED). Conditions: Breast Cancer (Early Breast Cancer). Interventions: DRUG: Removing Endocrine Therapy. Primary outcome measures: Relapse-free interval , At 5 years after the last treatment. Brief summary: The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life. All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.