ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer

Hurvitz, SA; Bachelot, T; Bianchini, G; Harbeck, N; Loi, S; Park, YH; Prat, A; Gilham, L; Boulet, T; Gochitashvili, N; Monturus, E; Lambertini, C; Nyawira, B; Knott, A; Restuccia, E; Schmid, P

Author(s): Hurvitz, SA; Bachelot, T; Bianchini, G; Harbeck, N; Loi, S; Park, YH; Prat, A; Gilham, L; Boulet, T; Gochitashvili, N; Monturus, E; Lambertini, C; Nyawira, B; Knott, A; Restuccia, E; Schmid, P;
Details: Publication Year 2022-10,Volume 18,Issue #32,Page 3563-3572
Journal Title: Future Oncology
Publication Type: Protocol
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: Humans; Female; Ado-Trastuzumab Emtansine/adverse effects; *Breast Neoplasms; Trastuzumab/adverse effects; Receptor, ErbB-2; Adjuvants, Immunologic/therapeutic use; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Randomized Controlled Trials as Topic; Her2; ado-trastuzumab emtansine; atezolizumab; cancer immunotherapy; early breast cancer
Department(s): Medical Oncology; Laboratory Research
PubMed ID: 36382554
Publisher's Version: https://doi.org/10.2217/fon-2022-0485
Open Access at Publisher's Site: https://doi.org/10.2217/fon-2022-0485
Terms of Use/Rights Notice: Refer to copyright notice on published article.

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