* T-DXd given with other treatments in HER2+ metastatic breast cancer
Research type
Research Study
Full title
A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with other Anti-cancer Agents in Patients with HER2-positive Metastatic Breast Cancer (DESTINY Breast07)
IRAS ID
299590
Contact name
Harmut Kristeleit
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-004531-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 30 days
Research summary
Trastuzumab deruxtecan (T-DXd, DS-8201a) is a type of anti-cancer drug called an ‘antibody drug conjugate’ (ADC) that targets cancer cells. One part of this study drug is a protein called a monoclonal antibody that recognises and attaches to cells that have a specific protein called HER2 on their surface. Another part of this drug contains a chemotherapy-like molecule called DXd. When trastuzumab deruxtecan binds to a HER2 protein on a cancer cell, the DXd is released into the cancer cell damaging or killing it.
We are doing this study to learn more about whether trastuzumab deruxtecan (T-DXd), given alone or in combination with other cancer treatments (durvalumab, pertuzumab, paclitaxel, paclitaxel plus durvalumab and tucatinib) will be safe and effective for the treatment of HER2-positive metastatic breast cancer (MBC). We hope that the results of this study will also help to better understand HER2-positive MBC and associated health problems.
While T-DXd has shown promising results in patients who have received two or more prior therapies for their cancer, there is much interest in exploring its effectiveness when alone and combined with other treatment regimens that have the potential to further slow-down cancer cell activity. This study will also explore the effectiveness of T-DXd alone and in combination with other cancer treatments in subjects diagnosed with no brain metastases or stable brain metastases (previously treated with radiation) and of T-DXd alone and in combination with tucatinib in subjects diagnosed with active brain metastases (not treated with radiation).
Up to 450 people with HER2-positive MBC from 15 countries will take part in this study over 3 years
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0262
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion