A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
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).
• Voluntarily signed informed consent and followed the program requirements;
• Females ≥18 and ≤75 years of age at the time of signing the informed consent;
• Expected survival time ≥6 months;
• Patients with HER2-positive invasive breast cancer confirmed by histologic examination;
• Clear hormone receptor (HR) status;
• Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy;
• Primary subjects without antitumor therapy for breast cancer;
• Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy;
• Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart;
⁃ Physical status score ECOG 0 or 1;
⁃ 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;
⁃ For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients should be using adequate and highly effective contraception throughout the treatment cycle and for 7 months after completion of treatment.