TROPION-Breast01
Research type
Research Study
Full title
A Phase 3, Open-label, Randomized Study of Dato-DXd Versus Investigator’s Choice of Chemotherapy in Participants With Inoperable or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy
IRAS ID
1004050
Contact name
Tania Veiga
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-005620-12
Clinicaltrials.gov Identifier
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 (from a choice of eribulin, capecitabine, vinorelbine, or gemcitabine - 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 inoperable or metastatic hormone receptor-positive, HER2- negative breast cancer. 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 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 700 patients will take part in approximately 21 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
London - Hampstead Research Ethics Committee
REC reference
21/LO/0625
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion