TRYbeCA-2 – TRial of erYaspase in Breast CAncer
Research type
Research Study
Full title
A Randomized Phase 2/3 Study of Eryaspase in Combination with Gemcitabine and Carboplatin Chemotherapy versus Chemotherapy Alone As First-Line Treatment in Patients with Metastatic or Locally Recurrent Triple-Negative Breast Cancer.
IRAS ID
251126
Contact name
Iain MacPherson
Contact email
Sponsor organisation
ERYTECH Pharma
Eudract number
2018-002211-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 7 days
Research summary
This study is intended to find out whether an experimental drug called Eryaspase could be a new treatment for patients with “triple negative” breast cancer that has recurred locally or has spread to other parts of the body. Eryaspase is an experimental drug that has not yet been approved by health authorities for the treatment of patients with cancer. Eryaspase is made up of red blood cells that have been changed to put a particular enzyme called asparaginase inside them. This enzyme removes a nutrient called asparagine from the bloodstream. Removing asparagine is hoped to cause the breast cancer cells to “starve” and die.
This study will evaluate whether adding Eryaspase to standard chemotherapy is better than using standard chemotherapy alone. Patients who volunteer to take part will either receive the experimental drug, Eryaspase, plus chemotherapy or chemotherapy only. Patients will be assigned, like the flip of a coin, to one of the following arms:
• Arm A: Eryaspase plus chemotherapy with gemcitabine/carboplatin combination
• Arm B: Chemotherapy (gemcitabine/carboplatin combination) alone
Patients will have to attend hospital to receive this treatment and for study procedures including blood tests, physical examinations, and radiology scans and will be monitored by the study doctor and the hospital staff involved in this study.REC name
West of Scotland REC 1
REC reference
19/WS/0017
Date of REC Opinion
20 Mar 2019
REC opinion
Further Information Favourable Opinion