A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have metastatic or locally recurrent inoperable triple-negative breast cancer. This purpose of this study is to learn more about the effectiveness of the investigational drug datopotamab deruxtecan (also known as Dato-DXd) compared to treatment with a single standard chemotherapy that will be selected by your doctor (from a choice of paclitaxel, nab paclitaxel, capecitabine, carboplatin, or eribulin), and to further determine the safety of Dato DXd in participants with locally recurrent inoperable or metastatic triple-negative breast cancer.

You will be in the study for approximately 3.5 years. However, the total length of treatment is unknown as you will continue to receive treatment in this study until your disease worsens, or you experience toxicity (side effects that are severe), you withdraw your consent from the study or it is decided by the study doctor or AstraZeneca to stop your participation. All drugs will be given either intravenously or they will be an oral tablet.

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

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05374512

uvacancertrials@hscmail.mcc.virginia.edu