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;
Parallel
BL-M07D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel
DrugOral administration of Capecitabine. Administration by intravenous infusion of Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel.
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 ratio (CBR) is defined as the percentage of patients with advanced cancer who achieved complete remission, partial remission, or stable disease for at least 6 months after treatment.
Click on the lead sponsor to view all of their trials.
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
