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A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

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Trial Profile

A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2026

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At a glance

  • Drugs Sacituzumab tirumotecan (Primary) ; Capecitabine; Carboplatin; Eribulin; Paclitaxel
  • Indications Advanced breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OptiTROP Breast03
  • Sponsors Klus Pharma

Most Recent Events

  • 30 Jul 2026 According to the Kelun Biotech media release, the company announced that the new indication application of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan has been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer based on the positive results this study.
  • 21 May 2026 Results presented Kelun Biotech media release.
  • 21 May 2026 Primary endpoint has been met. (Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR))

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