A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer
The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting
- EligibilityCriteria: Key Inclusion Criteria:  Histologically and/or cytologically confirmed TNBC. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease. Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease. At least one measurable lesion per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization. A life expectancy of at least 3 months. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator. Adequate organ and bone marrow function.  Key Exclusion Criteria:  Active second malignancy. Uncontrolled or clinical significant cardiovascular disease. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. Active infection requiring systemic therapy within 2 weeks of randomization. Active hepatitis B or hepatitis C virus infection. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. Known hypersensitivity to SKB264 or its excipients. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors. Prior treatment with the same investigator's choice chemotherapy (except taxane). Pregnant or lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult