ABCSG 56 / SASCIA
Status: Treatment Phase & Follow-up
| Study Start: | AT: FPI 09/2022 | Global: FPI 12/2020 (GER) |
| Coordinating Investigator: | AT: Balic, Marija |
| Sample Size: | AT: 50 | Global: 1332 |
Description and status:
The ABCSG 56 / SASCIA is a GBG-sponsored, randomized, open-label, postneoadjuvant Phase III study evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate, in primary HER2-negative breast cancer patients with high relapse risk after standard neoadjuvant treatment. The primary objective of the study is to compare invasive disease-free survival (iDFS) and overall survival (OS) between patients treated with sacituzumab govitecan and patients who received treatment of physician’s choice.
In addition, various biomarker analyses will be performed to investigate translational endpoints.
The Recruitment was ended globally on 23 January 2024 with an over-recruitment of 1.391 patients. In Austria, a total of 34 patients were included at 13 trial sites.
The regular end of study is set for the beginning of 2027. Subsequently, the ETERNITY project is planned, a registry for the long-term follow-up of safety and efficacy parameters of former SASCIA patients.
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