*Tropion-Breast-05
Research type
Research Study
Full title
A Phase III, Open-label, Randomised Study of Datopotamab-Deruxtecan (Dato-DXd) in combination with 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)
IRAS ID
1007219
Contact name
Nicola Dee
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-003277-28
Research summary
This study is being done to learn whether an investigational drug called datopotamab deruxtecan (Dato-DXd) given in combination with another investigational drug called durvalumab will be effective and safe for the treatment of triple-negative breast cancer that expresses a protein called PD-L1. This study will compare the investigational treatments with standard chemotherapy (either paclitaxel, nab-paclitaxel or gemcitabine plus carboplatin) known as Investigator’s Choice of Chemotherapy (ICC) given in combination with pembrolizumab.
Dato-DXd is a new type of targeted therapy. It consists of two linked parts: an antibody (datopotamab) and a chemotherapy drug (deruxtecan, or DXd). When Dato-DXd binds to TROP2 on a cancer cell, DXd is released into the cell, damaging or killing it.
Durvalumab is a type of anti-cancer drug called immunotherapy that targets cancer cells by blocking the signal that prevents the immune system from seeing the cancer cell, allowing the immune system to then attack and kill the cancer cells. Both Dato-DXd and durvalumab are given by intravenous infusion once every 3 weeks.
Patients who meet the screening criteria will be randomly assigned to one of two treatment arms, Dato-DXd with durvalumab or ICC with pembrolizumb. Patients have a 50% (1 in 2) chance of receiving Dato-DXd versus one of the ICCs.Approximately 550 patients will take part in approximately 22 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
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0032
Date of REC Opinion
28 Sep 2023
REC opinion
Further Information Favourable Opinion