DS8201-A-U302, Phase 3, HER2-Positive breast cancer
Research type
Research Study
Full title
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY OF DS-8201A, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE, VERSUS ADO-TRASTUZUMAB EMTANSINE (T-DM1) FOR HER2-POSITIVE, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS PREVIOUSLY TREATED WITH TRASTUZUMAB AND TAXANE
IRAS ID
252328
Contact name
Peter Schmid
Contact email
Sponsor organisation
Daiichi Sankyo, Inc
Eudract number
2018-000222-61
Clinicaltrials.gov Identifier
127553, IND
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
Breast cancer remains the most common cancer and the second leading cause of cancer mortality in women globally. In 2015, there were 2.4 million new cancer cases leading to 523,000 deaths worldwide. Approximately 20% of breast cancer cases test positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. HER2-positive breast cancers tend to be more aggressive and have worse outcomes than other types of breast cancer.
This study involves research of a potential new drug, DS-8201a, that is being developed for cancer treatment. It will compare the activity of DS-8201a in potential participants with HER2-positive, versus ado-trastuzumab emtansine (T-DM1). The comparator drug (T-DM1) is approved in the United Kingdom for HER2 positive breast cancer.
Depending on which treatment group participants are in, they will take DS-8201a or the comparator treatment. Since the study is open label the participants will know weather they are receiving the study drug or comparator.
The study comprises of a screening part (up to 28 days), a Treatment period and a Follow-up period.It is expected that about 500 patients will participate around the world. In the UK it is expected that the study will take place in 10 sites.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1767
Date of REC Opinion
7 Feb 2019
REC opinion
Further Information Favourable Opinion