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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: 27 Jul 2026

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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

  • 24 Jun 2026 According to a Gilead Sciences media release, Sara Tolaney is the principal investigator of the trial.
  • 24 Jun 2026 According to a Gilead Sciences media release, company announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the first line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
  • 23 Jun 2026 According to a Gilead Sciences media release, company today announced that Based on results from ASCENT-03 study the European Commission (EC) has granted marketing authorization for Trodelvy as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.

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