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A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients with Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed At Least One Line of Chemotherapy

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Trial Profile

A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients with Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed At Least One Line of Chemotherapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2025

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At a glance

  • Drugs Sacituzumab Tirumotecan (Primary) ; Capecitabine; Eribulin; Gemcitabine; Vinorelbine
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms OptiTROP-Breast02
  • Sponsors Sichuan Kelun-Biotech Biopharmaceutical

Most Recent Events

  • 18 Oct 2025 According to the Sichuan Kelun-Biotech Biopharmaceutical Media Release, data from the trial were presented at the 2025 European Society for Medical Oncology (ESMO) Congress held in Berlin, Germany.
  • 18 Oct 2025 Results presented in the Sichuan Kelun-Biotech Media Release
  • 23 Sep 2025 According to a Kelun Pharmaceutical media release, results form this study will be presented as a Proffered Paper at ESMO 2025 which will be held in Berlin, Germany, from October 17 to 21.

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