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A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

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Trial Profile

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 May 2025

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At a glance

  • Drugs Sacituzumab govitecan (Primary) ; Carboplatin; Gemcitabine; Paclitaxel
  • Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCENT-03
  • Sponsors Gilead Sciences

Most Recent Events

  • 23 May 2025 According to a Gilead Sciences media release, detailed results from the ASCENT-03 study will be presented at a future medical meeting and discussed with regulatory authorities.
  • 23 May 2025 According to a Gilead Sciences media release, Dr. Javier Cortes is the principal investigator of the ASCENT-03 study.
  • 23 May 2025 Primary endpoint (Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1) has been met, according to a Gilead Sciences media release.

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