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The purpose of this study is to determine whether an investigational drug called datopotamab deruxtecan (also known as Dato-DXd) is as good or better at treating locally recurrent inoperable or metastatic triple-negative breast cancer, as compared to a single standard chemotherapy.
Dato-DXd is an investigational drug, which means it is not yet approved by the U.S. Food and Drug Administration (FDA). The chemotherapy options used in this study are FDA-approved.
Participants will be randomly assigned to either Dato-DXd or standard chemotherapy. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group. The study team will discuss the dosing schedule with each participant.
Total study participation will last approximately three and a half years.
1. Over the age of 18
2. Locally recurrent inoperable triple negative breast cancer (TNBC), that cannot be treated with curative intent, or metastatic TNBC.
3. No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
4. Not a candidate for PD-1/PD-L1 inhibitor therapy
Detailed eligibility will be discussed when reaching out to the study team.
Upper East Side - Manhattan
Brooklyn
Open to Enrollment
