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