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Clinical trial

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)

NCT06112379 is registered in ClinicalTrials.gov with AstraZeneca as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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)
Lead sponsor
AstraZeneca
Phase
Phase 3
Overall status
Active, not recruiting
Start date
November 14, 2023
Completion date
September 23, 2032
Enrollment
1,902 (actual)
Sites
283

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer