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Clinical Trial Active — Not Recruiting Phase III NCT06112379

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer — Active Not Recruiting • Phase III •…

📅 13 Jul 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT06112379
Start
2023-11-14
Completion
2028-11-20
ClinicaliQ Trial Snapshot
  • A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer — Active Not Recruiting • Phase III • Oncology • NCT06112379.
  • Trial comparing a new drug combination (Dato-DXd plus durvalumab) against standard chemotherapy plus pembrolizumab for triple-negative breast cancer.

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What This Trial Is Studying

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer. Conditions: Breast Cancer Interventions: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Capecitabine, Olaparib Lead Sponsor: AstraZeneca Planned Enrollment: 1902 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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