A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
Trial Parameters
Brief Summary
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. Women aged ≥18 years and ≤75 years at the time of written informed consent; 3. Expected survival time ≥12 weeks; 4. Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer; 5. Provide the latest tumor tissues to the central laboratory for HER2 and HR detection; 6. Meet the treatment requirements in the plan; 7. Must have at least one measurable target lesion that meets the RECIST v1.1 definition; 8. ECOG 0 or 1; 9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 10. Organ function level must meet the requirements; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, serum pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) should use adequate, high