This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast cancer.
Voluntarily sign the informed consent form and agree to comply with the protocol requirements；
Female patients aged ≥18 years and ≤75 years at the time of signing the informed consent form；
Life expectancy ≥12 weeks；
Locally recurrent or metastatic breast cancer that is hormone receptor (HR)-positive and HER2-low expressing；
Received surgery, curative radiotherapy, immunotherapy, or other systemic anti-tumor therapies within 4 weeks prior to the first dose;
Intolerance to the control drug or presence of other contraindications to the control drug;
Prior treatment with anti-HER2 therapy;
Prior treatment with an ADC (antibody-drug conjugate) using a camptothecin derivative as the payload;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator