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

Trial Details

NCT ID
NCT06279364
Phase
PHASE3
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • SKB264
  • Paclitaxel
  • Nab-paclitaxel
  • Capecitabine
  • Eribulin
  • Carboplatin
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility 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 inhibi…

For full eligibility, visit ClinicalTrials.gov.

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