“BARBICAN” is a new trial on board. This time, thanks to Professor Peter Schmidt´group and the Queen Mary University of London. BARBICAN is an international, randomised, open-label, Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer.
Triple-negative breast cancer (TNBC) cells do not express both the estrogen and the progesterone receptor. In addition, these cancer cells do not express the HER2 protein. TNBC accounts for approximately 15-25% of all breast cancer cases, and the current standard of care of these tumors is very limited. Although some previous studies have reported benefit in the use of targeted therapies in metastatic disease, newly diagnosed, non-metastatic TNBC patients have very few therapeutic options.
The BARBICAN study evaluates the application of a specific therapeutic combination to non-metastatic TNBC patients, where the only current treatment available is chemotherapy.
This trial compares the addition of ipatasertib (an AKT-inhibitor) to atezolizumab (an anti-PD-L1) plus neoadjuvant chemotherapy (NACT). The main objectives of this study include two different primary endpoints. Clinical endpoint: compares the pathologic complete response (pCR) rates of NACT plus atezolizumab with NACT plus atezolizumab plus ipatasertib in patients with or without PIK3CA/AKT1/PTEN genetic alterations. Biological endpoint: determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of an immune response over adding atezolizumab to chemotherapy in all treated patients.
Overall, we expect to recruit 142 patients in the UK, Germany and Spain. We also expect a total of 40 patients within 15 different sites of Spain, with an estimated accrual period of 12 months. We believe that this trial will open new perspectives in the use of targeted therapies in TNBC patients.
Author: Leonardo Mina