WO39392 IMpassion 031 ATEZOLIZUMAB or PLACEBO + NAB-PACLITAXEL + CHEMO
Research type
Research Study
Full title
Title: A Phase III Randomised Study to Investigate the Efficacy and Safety of Atezolizumab (Anti−PD-L1 Antibody) in Combination with Neoadjuvant Anthracycline/Nab-paclitaxel Based Chemotherapy Compared with Placebo and Chemotherapy in Patients with Primary Invasive Triple-Negative Breast Cancer
IRAS ID
224828
Contact name
Professor Samreen Iram Ahmed
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2016-004734-22
Duration of Study in the UK
4 years, 4 months, 30 days
Research summary
Breast cancer is the most common cancer in the UK. It is the second most common invasive cancer in the world and the most common cause of cancer-related deaths in women.
The purpose of this research study is to compare the effects, good or bad, of chemotherapy (in this study, the chemotherapy drugs are known as nab-paclitaxel, doxorubicin and cyclophosphamide) in combination with a drug called atezolizumab (treatment arm A) or placebo (treatment arm B) (an inactive substance that looks like atezolizumab) in patients diagnosed with primary invasive triple-negative breast cancer (TNBC). TNBC is a form of breast cancer that has been tested and found to be negative for human epidermal receptor-2 (HER2) receptors, oestrogen receptors, and progesterone receptors.
Patients recruited onto treatment arm A and B will receive 20 weeks of chemotherapy ± atezolizumab (arm A) or placebo (arm B) followed by breast cancer surgery. Patients in arm A will continue to receive atezolizumab after the breast surgery for a further 33 weeks whilst patients in arm B will not receive any further study related treatment and will continue to be monitored for this period.
Atezolizumab is a type of drug called a PD-L1 antagonist and is a form of cancer immunotherapy that affects your immune system by blocking the programmed death ligand 1 (PD-L1) pathway. By blocking the PD-L1 pathway, atezolizumab may help the immune system stop or reverse the growth of tumours. The drug may help the immune system to recognise and fight off cancer cells. Patients will have safety assessments and be monitored throughout the study.
In the world, 204 patients will be recruited and 102 patients will be recruited to each treatment arm. In the UK, approximately 12 patients will be recruited onto the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0294
Date of REC Opinion
21 Jul 2017
REC opinion
Further Information Favourable Opinion