A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.
• Sign the informed consent form voluntarily and follow the protocol requirements;
• Women aged ≥18 years and ≤75 years at the time of written informed consent;
• Expected survival time ≥6 months;
• Patients with histologically confirmed HER2-positive invasive breast cancer;
• Before neoadjuvant therapy, the clinical TNM staging was T1-4, N0-3, M0 (excluding T1N0) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system;
• The presence of residual invasive cancer confirmed by postoperative pathological examination must meet one of the conditions specified in the protocol;
• Previous neoadjuvant therapy should meet the prescribed treatment conditions;
• Had received radical mastectomy;
• Determine hormone receptor (HR) status;
⁃ The interval between radical surgery and randomization was at least 3 weeks and at most 12 weeks;
⁃ ECOG score 0 or 1;
⁃ The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
⁃ No blood transfusion within 14 days before the first use of the study drug and no use of colony-stimulating factors were allowed;
⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients should use adequate and highly effective contraception during the entire treatment cycle and for 7 months after the end of treatment.