This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after failure of prior endocrine therapy.
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age ≥ 18 years;
Expected survival time ≥ 3 months;
Previously treated with ADC drugs that use topoisomerase I inhibitors as the toxin or target EGFR and/or HER3;
Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
Previous treatment with anthracycline drugs where the equivalent cumulative dose of doxorubicin exceeds 360 mg/m²;
History of severe cardiovascular or cerebrovascular diseases;
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator