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;
Parallel
BL-M07D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
DS-8201
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Clinical Benefit Rate(CBR)
Clinical Benefit Rate (CBR): The proportion of subjects who were randomized and received at least one dose of the study drug, and whose best overall response (BOR) according to RECIST v1.1 criteria was complete response (CR), partial response (PR), or stable disease (SD) lasting no less than 24 weeks.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
