A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
• Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
• Female patients aged 18 to 75 years;
• Expected survival time ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
• Confirmed PD-L1 expression positivity by central laboratory testing;
• No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
• Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
⁃ Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
⁃ No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
⁃ Organ function levels must meet the protocol-specified requirements;
⁃ Urine protein ≤ 1+ or \< 1000 mg/24 h;
⁃ For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.