Randomised, multicentre phase II study of bevacizumab and paclitaxel induction followed by atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer: protocol for the INDUCE trial (JBCRG-M10).

introductionAddition of bevacizumab and paclitaxel as induction therapy prior to standard atezolizumab and nab-paclitaxel in patients with programmed death-ligand 1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) may help to overcome vascular endothelial growth factor-associated resistance mechanisms that limit the immune-mediated antitumour efficacy of atezolizumab and nab-paclitaxel. METHODS AND ANALYSIS: The Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+TNBC (INDUCE) study is a multicentre, randomised, open-label, phase II trial designed to evaluate the efficacy and safety of two cycles of induction therapy with bevacizumab and paclitaxel followed by atezolizumab and nab-paclitaxel compared with standard atezolizumab and nab-paclitaxel in patients with PD-L1-positive mTNBC. The primary outcome of the study is progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumours, V.1.1. We have estimated that 89 PFS events are needed to allow a power of 80% to detect a difference between treatment groups at a one-sided significance level of 10% in this study. The target sample size is set to 106 patients to account for dropouts. ETHICS AND DISSEMINATION: The study protocol and informed consent form have been approved by the Certified Research Review Board at the Nagoya University Graduate School of Medicine, Nagoya, Japan. Study results will be presented at international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: jRCTs041240039 NCT06793553.