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.
Voluntarily sign the informed consent and follow the requirements of the protocol;
Women aged ≥18 years and ≤75 years at the time of written informed consent;
Expected survival time ≥12 weeks;
Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;
Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks before the first dose;
Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control group or other contraindications;
Previous treatment with anti-HER2 drugs;
Prior ADC drug therapy with camptothecin derivative as toxin;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator