A Phase 3 Open-label, Randomised Study of DatopotamabDeruxtecan (Dato-DXd) With or Without Durvalumab VersusInvestigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual InvasiveDisease in the Breast

Contact:

NCT Number:

Protocol:

AAAU5921

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to learn more about whether an investigational drug called datopotamab deruxtecan (also called Dato-DXd), either alone or in combination with another investigational drug called durvalumab, will work and be safe for the treatment of Triple Negative Breast Cancer TNBC. The term TNBC refers to the fact that the cancer cells do not have estrogen or progesterone receptors (ER or PR) and also do not make any or much of the protein called HER2 (human epidermal growth factor receptor 2). (The cells test negative on all 3 tests.) TIn this study, we will be comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years old or older Must not have known active liver disease Cannot be currently pregnant, breast feeding or planning to become pregnant

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032