* T-DXd with or without Pertuzumab vs SoC in HER2+ 1L Met Breast Cancer
Research type
Research Study
Full title
Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
IRAS ID
298657
Contact name
Caroline Michie
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-004074-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 5 months, 31 days
Research summary
The purpose of this study is to explore if the investigational drug trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with another medication, pertuzumab, is effective in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.
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 drug is a protein called a monoclonal antibody (trastuzumab) that recognizes 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 deruxtecan, or DXd. When T-DXd binds to a HER2 protein on a cancer cell, the DXd molecule is released into the cancer cell, damaging or killing it.
Patients that meet the screening criteria will be randomly assigned a study treatment (“randomly assigned” means that whatever treatment given to each patient will be by chance, like flipping a coin or drawing names out of a hat). There will be three treatment arms in the study: T-DXd with pertuzumab-matching placebo, T-DXd with pertuzumab and the standard of care treatment (taxane [docetaxel or paclitaxel], trastuzumab and pertuzumab). Approximately 1134 participants will be recruited from across the world from approximately 300 study sites.
The study involves a screening period, a treatment period, and a follow up period (after study treatment is discontinued). Patients who decide to take part in the study will have to attend for regular clinic visits for blood, urine and other safety tests to be performed along with scans for cancer measurement. The research study is planned to go on for about 5 years.REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0120
Date of REC Opinion
22 Jul 2021
REC opinion
Further Information Favourable Opinion