DESTINY-Breast12
Research type
Research Study
Full title
An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)
IRAS ID
296617
Contact name
Rizwana Sangrar
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-005048-46
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 22 days
Research summary
Despite advances in diagnosis and treatment 10 to 15% of women diagnosed with Metastatic Breast Cancer have cancer that has metastasized to the brain, this number can be as high as approximately 50% in women with HER2-positive breast cancer.
The investigational study drug Trastuzumab Deruxtecan is an antibody-drug conjugate consisting of an anti-HER2 antibody, which means that it targets the HER2 expressing tumours that helps the cancer grow, divide and spread. The purpose of this study is to learn more about how Trastuzumab Deruxtecan might provide benefit to patients with metastatic breast cancer. This study is designed to see if how effective Trastuzumab Deruxtecan is in specifically treating patients with brain metastases as well as their breast cancer.
The study is single arm, open-label, meaning all participants will know that they receive the same drug. Trastuzumab Deruxtecan will be administrated via an intravenous (IV) infusion, which means it will be given as a slow injection (infusion) into a vein. The study medication dose of infusion is 5.4 mg/kg, so the amount of study medication participants receive will be calculated based on their weight.
The study is planned to last for approximately three years and include around 500 patients from approximately 19 countries.
The sponsor of this study is AstraZeneca AB except in Japan, where and Daiichi-Sankyo is the local sponsor.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0192
Date of REC Opinion
15 Sep 2021
REC opinion
Further Information Favourable Opinion