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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Nov 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

  • 30 Oct 2025 According to an Gilead Sciences media release, data from this trial was presented at the 2025 European Society for Medical Oncology (ESMO) Congress.
  • 19 Oct 2025 According to Gilead Sciences media release, the company plans to discuss results from ASCENT-03 and ASCENT-04 with US FDA and other global regulators .
  • 19 Oct 2025 Results presented in the Gilead Sciences Media Release.

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