This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;
Expected survival time ≥12 weeks;
Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;
Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.
Previously received ADC drug therapy with camptothecin derivatives as toxins.
History of severe cardiovascular or cerebrovascular disease within six months before screening.
Concomitant pulmonary disease resulting in severely impaired lung function.
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator