A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

The University of Virginia seeks adults ages 18 and over with Triple Negative Breast Cancer (TNBC) for a research study. You will be eligible if you have locally recurrent inoperable or metastatic TNBC. The objective of this study is to determine the superiority of the study drug Dato-DXd combined with durvalumab relative to Investigator’s Choice of Chemotherapy combined with pembrolizumab in participants.

You may be eligible for this study if:
• You have previously untreated locally recurrent inoperable or metastatic TNBC
• PD-L1 positive
• No active brain metastases

Study involves blood draws, eye exams, brain scan, and Computed Tomography (CT) scan.

There will be 2 arms (or groups) of this study, you will be randomized (assigned by chance) into one of the two arms. The study drugs for each arm are as follows:
Arm 1: Dato-DXd and Durvalumab (both administered by IV/intravenously)
Arm 2: Investigator’s Choice of Chemotherapy and Pembrolizumab administered by IV/intravenously

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.