Phase III Study Comparing BL-M07D1 and T-DM1 as Adjuvant Treatments for HER2-positive Breast Cancer After Neoadjuvant Therapy

What this Trial Is About

Researchers are evaluating BL-M07D1 compared to T-DM1 for the adjuvant treatment of HER2-positive breast cancer in women who have residual invasive cancer after neoadjuvant therapy. This phase III, randomized, open-label, multicenter study aims to assess the effectiveness and safety of BL-M07D1 in this specific breast cancer population. Participants receive either BL-M07D1 or T-DM1 through intravenous infusion every three weeks for each treatment cycle. Those who benefit clinically may continue receiving additional cycles. Treatment may stop if the disease progresses, intolerable side effects occur, or for other reasons. This study follows participants for up to approximately 77 months to monitor outcomes. During the trial, participants will undergo regular assessments to measure invasive disease-free survival, disease-free survival, distant recurrence-free interval, overall survival, and treatment-related adverse events. The study includes scheduled visits for treatment administration and safety monitoring. Participants are involved for the duration of treatment and follow-up, which may last up to about 6.5 years.

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy