Status: Treatment Phase & Follow-up

An open-label, two-arm, randomized, single-stage phase II study of ATezolizumab in combination with dual HER2 blockade plus epirubicin as NEoadjuvant therapy for HER2-positive early breast cancer

Coordinating Investigators: Richard Greil (Salzburg),
Michael Gnant (Vienna)
Start of study: 07/2020(national)
Sample size: 58
Sponsor: ABCSG

Description and status:

The ABCSG 52 / ATHENE study is investigating the efficacy and safety of a neoadjuvant immunochemotherapy regimen consisting of atezolizumab, trastuzumab, pertuzumab and epirubicin in HER2-positive early breast cancer patients in regards to pathologic complete response (pCR). Furthermore, this study project includes a comprehensive translational research program with a corresponding study endpoint. This academic Austrian-wide research project was conducted at 9 study sites. On July 3rd, 2020, the first patient was randomized into the study at the trial site in Salzburg under the supervision of ABCSG vice president Richard Greil. Due to the strong performance of the Austrian trial sites despite being launched in the midst of and accompanied by the challenges of the COVID-19 pandemic, the last patient could be enrolled in the beginning of December 2021 at the top recruiting site in Innsbruck under PI Daniel Egle and study enrollment was closed accordingly in time. The database lock occurred in August 2022 and the main study results were successfully presented at ESMO Breast 2023 by lead author Gabriel Rinnerthaler.

Share on