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

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 985 participants in total. It began in 2025-06-05 with a primary completion date of 2028-12.

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 sign the informed consent form and comply with protocol requirements; 2. Female aged ≥18 and ≤75 years at the time of signing the informed consent form; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histological examination; 5. Clinical stage II-III confirmed based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system before neoadjuvant therapy; 6. Treatment-naive trial participants who have not received any anti-tumor therapy for breast cancer; 7. Trial participants agree to undergo mastectomy or breast-conserving surgery after completion of neoadjuvant therapy; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Organ function levels must meet the requirements; 10. 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. Exclusion Criteria: 1. History of breast cancer and tumor treatment; 2. Diagnosis of other primary malignancies within 5 years before the first dose; 3. History of severe cardiovascular or cerebrovascular disease within 6 months before screening; 4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 5. Hypertension inadequately controlled with two antihypertensive medications; 6. Concurrent pulmonary disease resulting in severe impairment of pulmonary function; 7. History of interstitial lung disease/interstitial pneumonia requiring steroid therapy, etc.; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 9. Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; 10. Patients with poorly controlled blood glucose; 11. Severe infection within 4 weeks before the first use of the study drug; active pulmonary inflammation at screening; 12. Receiving systemic corticosteroid therapy at \>10 mg/day prednisone or equivalent anti-inflammatory activity, or any form of immunosuppressive therapy, within 2 weeks before the first dose; 13. Known hypersensitivity to the study treatment or any study drug excipients or other monoclonal antibodies; 14. Patients unsuitable for receiving the investigational drug; 15. History of autologous or allogeneic stem cell transplantation or organ transplantation; 16. Severe neurological or psychiatric disorders; 17. Subjects with clinically significant bleeding or a significant bleeding tendency within 4 weeks before signing informed consent; 18. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.; 19. Subjects planning to receive, or having received, live vaccines within 28 days before the first dose; 20. Presence of other severe physical or laboratory abnormalities or poor compliance, etc., which may increase the risk of participating in the study or interfere with study results, or patients deemed unsuitable for participation in this study by the investigator.

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