Translational Studies and Projects
Translational research (TR) studies, which aim at developing, testing, and validating new biomarkers, tumor signatures or assays, are increasingly gaining significance within modern oncology. These studies are often the basis for novel diagnostic tools and thereby for targeted and personalized therapies, which are becoming more common in clinical trials and daily clinical practice. ABCSG is involved in – and operationally conducts – numerous translational research projects and collaborations as the extensive collection of biosamples and data from former ABCSG trials is a valuable resource for such projects.
The TraX&Vields project in collaboration with Cepheid is one of ABCSG’s largest endeavors, as it includes work packages for multiple former ABCSG trial patient cohorts. The main aim of all work packages is twofold: the Cepheid GeneXpert Breast Cancer STRAT4 is a novel test to reliably, reproducibly, and quantitatively test common tumor markers using their mRNA expression levels. This test is to be validated in a number of ABCSG trial patient cohorts and has already achieved CE-certification in some countries. Secondly, a prognostic breast cancer signature to predict the recurrence risk of early breast cancer patients is to be developed and validated. In 2020, a new predictive breast cancer signature (Xpert Insight) has come into focus, but strategic business decisions within Cepheid have led to discontinuing the commercial development of the Xpert Insight signature in the meantime.
Work is continuing on a number of Cepheid work packages in parallel: for the Trax&Vields-05 project (ABCSG 34 cohort), clinical follow-up data was collected from former ABCSG-34 trial patients to validate the STRAT4 test. Results from this work package have been published in The Breast in 2025 (https://doi.org/10.1016/j.breast.2025.104633).
The laboratory work for the TraX&Vields-02 work package (ABCSG 8), validating the STRAT4 and Breast Cancer Insight has been finalized. The Xpert Insight test has further been successfully validated in the TraX&Vields-07 work package focusing on the ABCSG 8 cohort.
In the ongoing work package TraX&Vield-03, concerning the ABCSG-12 cohort, former ABCSG 12 sites are involved in collecting clinical follow-up data of ABCSG 12 patients and in centralizing tumor samples of these patients in the ABCSG central research facility in Vienna. Laboratory analysis of centralized ABCSG 12 samples to validate the STRAT4 test and prognostic signature are then planned subsequently.
The ABCSG TR ProCan collaboration is an analysis of protein expression to develop a proteomic signature of distant recurrence in HR-positive early breast cancer. The Children’s Medical Research Institute (CMRI) in Sydney Australia, is the trial sponsor who approached ABCSG to support this interesting endeavor. HE-stained tumor tissue slides from the ABCSG 6 trial cohort, and afterwards also the ABCSG 8 trial patients, were facilitated for this project. The results of all analyses have been evaluated, with some subprojects emerging from the main question as well, so results will be published in 2026.
ABCSG TR Artera is a digital imaging project in cooperation with the US based company Artera to develop a breast cancer signature, based on HE-stained tumor tissue slides, via artificial intelligence methods that integrate machine learning algorithms. Digitized HE-slides and clinical data of ABCSG 6 were used for model optimization and digitized HE-slides and clinical data of ABCSG 8 were used for model validation. The final model – which additionally to the ABCSG trial cohorts includes WSG’s ADAPT and PlanB as well as NSABP B14, B20, B34 and B42 study data – was locked in 2025 and initial results were presented in ASCO 2025 as well as SABCS 2025.
ABCSG TR Ataraxis is a digital imaging project in cooperation with the US based company Ataraxis AI to validate a prognostic and predictive foundation model-based AI test in breast cancer using digitized HE-slides and clinical data of ABCSG 6 and ABCSG 8.
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