A-BRAVE Trial
Research type
Research Study
Full title
Adjuvant treatment for high-risk triple negative breast cancer patients with the anti-pd-l1 antibody Avelumab: A phase III randomized trial
IRAS ID
229507
Contact name
Valentina Guameri
Contact email
Sponsor organisation
University of Padova
Eudract number
2016-000189-45
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 6 months, 30 days
Research summary
This study is being carried out to see if Avelumab is effective in treating patients with high risk triple negative breast cancer (TNBC).
Breast cancer is the most common malignancy in women and is the leading cause of cancer related death in European women. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises <20% of breast cancers, and remains the subtype with poorest outcome. There is a significant need to develop new therapies for this group of patients.
Immunotherapy is emerging as a promising strategy for anti-cancer treatments, where the immune system helps the body fight against tumour cells. Avelumab is designed to stop a protein called PDL1 (programmed death-ligand 1) being expressed on the cancer. PDL1 helps to camouflage the cancer, preventing the body’s immune system from identifying the cancer and fighting it. Avelumab works against PDL1, allowing the immune system to recognise the tumour cells as foreign bodies and attack them.
The main purpose of this study is to see if Avelumab is an effective treatment for TNBC. The study is for patients who have received the standard treatments of surgery and chemotherapy treatment, and who have features that maybe associated with a higher risk of recurrence. Also included is a biomarker component to find out which patients tumours have certain molecular traits that may derive more benefit from this treatment. The study will determine whether 1-year administration of the Avelumab improves survival in patients at risk of recurrence.
The study will recruit 335 patients, aged 18+, with high risk TNBC. Consenting eligible patients will be randomly placed into one of two groups. One group will receive Avelumab, and the other group will receive no treatment and will be under observation (as per normal clinical care).REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0071
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion