DS8201-A-U303, HER 2 - Low Breast Cancer
Research type
Research Study
Full title
A Phase 3, Multi-center, randomized, open label, active-controlled trial of DS-8201A, an ANTI-HER2-ANTIBODY drug conjugate (ADC), versus treatment of physician's choice for HER2LOW, unresectable and/or metastatic breast cancer subjects
IRAS ID
258125
Contact name
Peter Hall
Contact email
Sponsor organisation
Daiichi Sankyo, Inc
Eudract number
2018-003069-33
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
127553, IND
Duration of Study in the UK
2 years, 0 months, 16 days
Research summary
Breast cancer is a life-threatening disease and remains the most common cancer and the first leading cause of cancer mortality in women globally. Breast cancer has a higher incidence rate in women (43.3 per 100,000) than any other cancer.
This is a randomised, 2-arm, open-label, multicentre study to compare the safety and efficacy of DS-8201a versus the investigator’s choice for HER2-low, unresectable and/or metastatic breast cancer patients.
Potential Participants will be assigned in a 2:1 ratio, which means that two patients will be assigned to the DS-8201a group for every one patient that is assigned to the comparator treatment group. Since this is open label, participants will know whether they are receiving the study drug or comparator.
• DS-8201a – the study drug is given via an intravenous infusion. The first infusion will be about 90 minutes. At other study visits may take less time. Participants will visit the study site once every 3 weeks for infusions. Each three-week period is known as a cycle.
• Comparator treatment (also referred to as doctor’s choice) which will be either:
o Capecitabine – given as an oral tablet two times a day for 14 days of a 3-week cycle
o Eribulin – given as an intravenous infusion (through the vein) on Day 1 and Day 8 every 3 weeks
o Gemcitabine – will be given as an intravenous infusion (through the vein) on Day 1 and Day 8 every 3 weeks
o Paclitaxel – will be given as an intravenous infusion (through the vein) once every 3 weeks or every week
o Nab-paclitaxel – will be given as an intravenous infusion (through the vein) once every 3 weeks
The study comprises of a screening part (up to 28 days), a Treatment period and a Follow-up period.
It is expected that about 540 patients will participate in approximately 161 sites around the world. In the UK it is expected that the study will take place in seven sites.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0026
Date of REC Opinion
15 Apr 2019
REC opinion
Further Information Favourable Opinion