Official Title: A randomised, open-label Phase II study to determine the contribution of ipatasertib to neoadjuvant chemotherapy plus atezolizumab in women with triple-negative breast cancer.
BARBICAN is an international, randomized, neo-adjuvant phase II trial in women with newly diagnosed, non-metastatic, high-risk, triple negative breast cancer. The study aims to evaluate the effects of adding ipatasertib to chemotherapy and atezolizumab in patients with and without PI3CA/AKT1/PTEN genetic alterations.
This is an open-label clinical trial with two different primary objectives. First, the study aims to evaluate the effects of adding ipatasertib to chemotherapy and atezolizumab in patients with and without PI3CA/AKT1/PTEN genetic alterations. Second, to determine whether adding ipatasertib to atezolizumab and chemotherapy increases the probability of immune response over adding atezolizumab to chemotherapy in all treated patients.
In addition, this study will also assess the relationship between the anticipated anti-tumour activity of the study treatment and biological characteristics of subjects’ tumour and blood sample derivatives at baseline and at the end of treatment to better define the optimal target population and to gain insight in resistance mechanisms to the study treatment.