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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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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: 06 Mar 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

    • 17 Oct 2024 Planned End Date changed from 1 May 2027 to 1 Jul 2028.
    • 17 Oct 2024 Planned primary completion date changed from 1 May 2027 to 1 Jul 2028.
    • 13 Sep 2022 Trial design, presented at the 47th European Society for Medical Oncology Congress

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