TROPION-Breast02

  • Research type

    Research Study

  • Full title

    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 (TROPION-Breast02)

  • IRAS ID

    1005082

  • Contact name

    Nicola Weston

  • Contact email

    nicola.weston@astrazeneca.com

  • Sponsor organisation

    AstraZeneca AB

  • Eudract number

    2021-005223-21

  • Clinicaltrials.gov Identifier

    NCT05374512

  • Research summary

    The purpose of this study is to learn more about the effectiveness of the investigational drug datopotamab deruxtecan (Dato-DXd) compared to treatment with single-agent standard chemotherapy selected by the doctor (ICC: paclitaxel, nab-paclitaxel, capecitabine, eribulin, carboplatin - this will be referred to as Investigator’s Choice of Chemotherapy (ICC) in the study), and to further determine the safety of Dato-DXd in patients with locally recurrent inoperable or metastatic triple-negative breast cancer, who are not candidates for PD-1/PD-L1 inhibitor therapy. Dato-DXd is a new type of anti-cancer drug called an “antibody drug conjugate” (ADC) that targets cancer cells expressing high levels of a specific molecule. One part of this investigational drug is a protein is a monoclonal antibody (datopotamab, or Dato) that recognizes and attaches to cells that have a specific protein called TROP2 on their surface. Another part contains a chemotherapy-like molecule called deruxtecan (DXd). When Dato-DXd binds to a TROP2 protein on a cancer cell, DXd is released into the cancer cell, damaging or killing it. Dato-DXd is given by an intravenous (IV) infusion once every 3 weeks. Patients that meet the screening criteria will be randomly assigned to one of two treatment arms, Dato-DXd or ICC. Patients have a 50% (1 in 2) chance of receiving Dato-DXd versus one of the ICCs. Approximately 600 patients will take part in approximately 24 countries in North and South America, Europe and Asia. This study involves screening, treatment and follow-up (after study treatment is discontinued) periods. Patients who decide to take part in the study will have to attend regular clinic visits for drug infusions, physical exams, as well as blood, urine and other safety tests, along with imaging scans for cancer measurement. The research study is planned to go on for about 5 years.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    22/SC/0071

  • Date of REC Opinion

    1 Apr 2022

  • REC opinion

    Further Information Favourable Opinion