Phase IIIII Study of BL-M07D1 With or Without Pertuzumab Compared to Taxane Plus Trastuzumab and Pertuzumab in Neoadjuvant Treatment for HER2-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating BL-M07D1 with or without Pertuzumab in the treatment of HER2-positive breast cancer before surgery. This phase II and III randomized, open, multicenter trial aims to assess the effectiveness and safety of these treatments compared to standard therapy with Taxane, Trastuzumab, and Pertuzumab. The study focuses on patients with stage II-III invasive HER2-positive breast cancer who have not previously received antitumor therapy for breast cancer. Participants receive BL-M07D1 with or without Pertuzumab through intravenous infusion in cycles lasting 3 weeks. Those who respond well may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping. The study includes a single-arm phase II followed by a randomized controlled phase III to compare treatments. During the trial, participants will undergo evaluations including surgery after neoadjuvant therapy, physical health assessments, and laboratory tests to monitor organ function and side effects. Researchers will measure outcomes such as the rate of complete pathological response, event-free survival, disease-free survival, overall survival, and treatment-related adverse events over approximately 48 months. The study lasts through treatment and follow-up to assess long-term effects and safety.

A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer