TROPION-Breast04 (Triple Negative Breast Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find the safest and most effective dose of an experimental drug called Dato-DXd (the study drug) in patients with triple negative breast cancer (TNBC) and HER2-negative breast cancer.
Breast Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with TNBC or HER2-negative breast cancer
- Have not started treatment for breast cancer
For more information about who can join this study, please contact the study team at breastcl@dm.duke.edu.
What is Involved?
If you choose to join the study, you will go through a screening period that lasts about 4 weeks. During this period, you will:
- Agree to send a tumor tissue sample for genetic testing
- Have a CT scan and MRI
- Have blood and urine tests, EKGs, and physical exams
If you are found to be eligible during screening, you will proceed to the study regimen portion. During period, you will get a random assignnment to 1 of 2 different groups:
Experimental arm - If you are in this group, you will get the study drug in combination with a drug callled durvalumab as an infusion (IV) into a vein every 3 weeks before your surgery.
Control arm - If you are in this group, you will get durvalumab combined with one of the following choices of chemotherapy:
- Doxorubicin/epirubicin + cyclophosphamide, followed by paclitaxel + carboplatin; OR
- Doxorubicin/epirubicin + cyclophosphamide, followed by paclitaxel; OR
- Carboplatin + paclitaxel; OR
- Capecitabine
Study Details
