Trial Profile

A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed Second-line or Above Prior Standard of Care

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 16 Apr 2025

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At a glance

Drugs Sacituzumab Tirumotecan (Primary) ; Capecitabine; Eribulin; Gemcitabine; Vinorelbine
Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
Focus Registrational; Therapeutic Use
Acronyms OptiTROP-Breast01
Sponsors Sichuan Kelun-Biotech Biopharmaceutical

12 Apr 2025 Results from this study published in Nature Medicine.
12 Apr 2025 Results presented in the a Sichuan Kelun-Biotech Biopharmaceutical media release.
12 Dec 2024 Planned End Date changed from 31 Dec 2024 to 31 Mar 2025.

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