NCT06891833 A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Trial Parameters

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Brief Summary

This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily signed informed consent and followed the program requirements; 2. Females ≥18 and ≤75 years of age at the time of signing the informed consent; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histologic examination; 5. Clear hormone receptor (HR) status; 6. Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy; 7. Primary subjects without antitumor therapy for breast cancer; 8. Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy; 9. Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart; 10. Physical status score ECOG 0 or 1; 11. Organ function levels must be met provided that blood transfusions are not permitted within 14 days prior to the first administration of study drug, colony-stimulating factors are not permitted, and so on;

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