Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 4, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07915739). This is a study registration, not published results. Lead sponsor: Mahidol University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1760 participants (ESTIMATED). Conditions: Breast Neoplasms. Interventions: RADIATION: Locoregional Radiotherapy With Internal Mammary Node Irradiation; RADIATION: Locoregional Radiotherapy Without Internal Mammary Node Irradiation. Primary outcome measures: Disease-Free Survival (DFS) , From randomization through 5 years. Brief summary: This multicenter randomized controlled trial evaluates whether internal mammary node irradiation (IMNI) improves oncologic outcomes in patients with breast cancer who have residual pathologically positive lymph nodes after neoadjuvant systemic therapy. Eligible participants will be randomly assigned in a 1:1 ratio to receive locoregional radiotherapy either with or without irradiation of the internal mammary lymph nodes. The primary outcome is disease-free survival. Secondary outcomes include overall survival, breast cancer mortality, locoregional recurrence-free survival, distant metastasis-free survival, and treatment-related toxicity, particularly cardiac and pulmonary toxicity. A total of 1,760 participants are planned to be enrolled across multiple centers in Thailand.