Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 21, 2026
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Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06279364). This is a study registration, not published results. Lead sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 537 participants (ACTUAL). Conditions: Triple Negative Breast Cancer. Interventions: DRUG: SKB264; DRUG: Paclitaxel; DRUG: Nab-paclitaxel; DRUG: Capecitabine; DRUG: Eribulin; DRUG: Carboplatin. Primary outcome measures: Overall Survival (OS) , Randomization up to approximately 40 months; Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) , Randomization up to approximately 28 months. Brief summary: 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