TROPION-Breast03
Research type
Research Study
Full title
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPIONBreast03)
IRAS ID
1006335
Contact name
Nicola Weston
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-002680-30
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn whether an investigational drug called datopotamab deruxtecan (Dato-DXd), either alone or in combination with another investigational drug called durvalumab, will be effective and safe for the treatment of triple-negative breast cancer. This study will compare the investigational treatments with treatments called capecitabine and pembrolizumab (Investigators Choice of Therapy) either alone or in combination. Dato-DXd is a type of anti-cancer drug called an “antibody-drug conjugate” that targets cancer cells expressing a high level of a specific surface protein, TROP2. It consists of two parts with a linker in between. One part is a monoclonal antibody (datopotamab, or Dato) that recognizes and attaches to TROP2. Another part is a chemotherapy-like molecule called 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 a study treatment. Patients have a 60% chance of being given the investigational treatments (either Dato-DXd with durvalumab or Dato-DXd alone). Approximately 1075 people will take part in this study in approximately 19 countries in North and South America, Europe and Asia-Pacific regions. This study involves screening, treatment, and follow up (after study treatment is discontinued or completed). Participants 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. This study is planned to last for about 8 years.
REC name
London - Riverside Research Ethics Committee
REC reference
22/LO/0662
Date of REC Opinion
29 Nov 2022
REC opinion
Further Information Favourable Opinion