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

Hurvitz, Sara A.; Bachelot, Thomas; Bianchini, Giampaolo; Harbeck, Nadia; Loi, Sherene; Park, Yeon Hee; Prat, Aleix; Gilham, Leslie; Boulet, Thomas; Gochitashvili, Nino; Monturus, Estefania; Lambertini, Chiara; Nyawira, Beatrice; Knott, Adam; Restuccia, Eleonora und Schmid, Peter (2022): ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. In: Future Oncology, Bd. 18, Nr. 32: S. 3563-3572

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1479-6694
• Sprache: Englisch