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A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Trial Profile

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Sacituzumab govitecan (Primary) ; Capecitabine
  • Indications HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCENT-05
  • Sponsors Gilead Sciences

Most Recent Events

  • 20 Sep 2023 Planned End Date changed from 1 Jan 2031 to 1 Aug 2031.
  • 20 Sep 2023 Planned primary completion date changed from 1 Jul 2027 to 1 Jun 2027.
  • 06 Jun 2023 Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology

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