A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + 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 sign the informed consent form and comply with protocol requirements;
• Female aged ≥18 and ≤75 years at the time of signing the informed consent form;
• Expected survival time ≥6 months;
• Patients with HER2-positive invasive breast cancer confirmed by histological examination;
• Clinical stage II-III confirmed based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system before neoadjuvant therapy;
• Treatment-naive trial participants who have not received any anti-tumor therapy for breast cancer;
• Trial participants agree to undergo mastectomy or breast-conserving surgery after completion of neoadjuvant therapy;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Organ function levels must meet the requirements;
⁃ For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy must be negative, and the patient must be non-lactating; all enrolled patients should adopt adequate highly effective contraceptive measures throughout the entire treatment cycle and for 7 months after treatment completion.