A Phase 3 Study of Datopotamab Deruxtecan With or Without Durvalumab Versus Investigator¿s Choice of Therapy in People with Stage 1-3 Triple-Negative Breast Cancer Remaining in the Breast and/or Lymph Nodes After Presurgical Chemotherapy


Full Title

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03) (WCG IRB)


Researchers are studying the safety and effectiveness of datopotamab deruxtecan (Dato-DXd) with or without durvalumab to treat breast cancer. The people in this study have stage 1, 2, or 3 triple-negative breast cancer. They still have cancer cells in their breast or underarm lymph nodes even after getting chemotherapy before surgery. Researchers are comparing the study treatment with capecitabine and/or pembrolizumab.

If you join this study, you will be randomly assigned to get one of these treatments:

  • Dato-DXd plus durvalumab
  • Dato-DXd alone
  • Capecitabine, pembrolizumab, or both

All of these medications are given intravenously (by vein) except for capecitabine, which is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have triple-negative breast cancer that is stage 1, 2, or 3.
  • Have cancer cells in the breast or underarm lymph nodes found during surgery, even though you had chemotherapy before surgery.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older


For more information or to see if you can join this study, please call Dr. Tiffany Traina’s office at 646-888-4558.




Phase III (phase 3)




ClinicalTrials.gov ID