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A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

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Trial Profile

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2025

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Durvalumab (Primary) ; Capecitabine; Carboplatin; Cyclophosphamide; Doxorubicin; Epirubicin; Olaparib; Paclitaxel; Pembrolizumab
  • Indications Early breast cancer; HER2 negative breast cancer; Triple negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROPION-Breast04
  • Sponsors AstraZeneca

Most Recent Events

  • 03 Jun 2025 Planned number of patients changed from 1728 to 1900.
  • 03 Jun 2025 Planned End Date changed from 28 Aug 2030 to 3 Nov 2032.
  • 03 Jun 2025 Planned primary completion date changed from 29 Mar 2028 to 20 Nov 2028.

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