ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer
Sara A Hurvitz, Thomas Bachelot, Giampaolo Bianchini, Nadia Harbeck, Sherene Loi, Yeon Hee Park, Aleix Prat, Leslie Gilham, Thomas Boulet, Nino Gochitashvili, Estefania Monturus, Chiara Lambertini, Beatrice Nyawira, Adam Knott, Eleonora Restuccia, Peter Schmid, Sara A Hurvitz, Thomas Bachelot, Giampaolo Bianchini, Nadia Harbeck, Sherene Loi, Yeon Hee Park, Aleix Prat, Leslie Gilham, Thomas Boulet, Nino Gochitashvili, Estefania Monturus, Chiara Lambertini, Beatrice Nyawira, Adam Knott, Eleonora Restuccia, Peter Schmid
Abstract
There is a strong rationale for combining HER2-targeted therapies with cancer immunotherapy to increase efficacy in breast cancer, particularly in the early-stage setting, where the immune system has not been weakened by heavy pretreatment. ASTEFANIA aims to evaluate the efficacy of adjuvant atezolizumab in combination with ado-trastuzumab emtansine in patients with high-risk, HER2-positive early breast cancer and residual disease following HER2-based neoadjuvant therapy. Eligible patients will be randomized to receive ado-trastuzumab emtansine in combination with either atezolizumab or placebo for 14 cycles within 12 weeks of primary surgery. The primary outcome is invasive disease-free survival and secondary outcomes include additional efficacy end points, safety and pharmacokinetics. The study plans to enroll 1700 patients across 32 counties. Clinical Trial Registration: NCT04873362 (ClinicalTrials.gov).
Keywords: HER2; ado-trastuzumab emtansine; atezolizumab; cancer immunotherapy; early breast cancer.
Source: PubMed