COGNITION-GUIDE - Genomics-Guided Targeted Post-Neoadjuvant Therapy in Patients with Early Breast Cancer: Study Design of a Multicenter, Open-Label, Umbrella Phase II Study

Pixberg C, Maurer C, Smetanay K, Straβl L, Hlevnjak M, Zapatka M, Wagner CV, Yazdanparast H, Kurzawa J, Erben V, Feng F, Hong C, Hübschmann D, Buschhorn L, Suppelna JP, Michel L, Heublein S, Fremd C, Zivanovic O, Sinn P, Stenzinger A, Haidinger R, Schumacher-Wulf E, Ditsch N, Loibl S, Fröhling S, Link T, Wimberger P, Blohmer JU, Hübner H, Fasching P, Janni W, Schlenk RF, Thewes V, Lichter P, Schneeweiss A (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Geburtshilfe und Frauenheilkunde Georg Thieme Verlag

DOI: 10.1055/a-2557-1876

Abstract

Background As part of the COGNITION diagnostic registry program, residual tumor material after neoadjuvant therapy (NAT) of patients with early breast cancer (eBC), who are still at high-risk for relapse after NAT, is analyzed by next generation sequencing to identify biomarkers and actionable alterations. This strategy aims to stratify patients for subsequent genomics-guided therapies to reduce the significant risk of metastatic dissemination and hence to improve disease-free survival. Patients and Methods COGNITION-GUIDE is a multicenter umbrella phase-II-trial to translate molecular biomarker profiles generated in the COGNITION platform into six molecular-guided post-neoadjuvant therapeutic options in addition to standard-of-care treatment. Patients can be allocated to immune checkpoint inhibition (PD-L1-antibody), PI3K inhibition, AKT inhibition, PARP inhibition, anti-Trop-2 antibody-drug-conjugate, HER2 inhibition or, in case of missing biomarkers, to observation for 12 months. The primary endpoint is invasive disease-free survival (IDFS) four years after surgery. Secondary endpoints include IDFS in each study arm separately, distant disease-free survival, overall survival and safety. 240 patients will be enrolled within four years. Conclusions The COGNITION-GUIDE trial, which was activated in June 2023 and will recruit in different centers in Germany, empowers a risk-adapted, biomarker-guided therapy escalation algorithm in eBC patients who are still at high risk of metastasis.

Authors with CRIS profile

Hanna Hübner Department of Obstetrics and Gynaecology Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

Deutsches Krebsforschungszentrum (DKFZ) DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Ruprecht-Karls-Universität Heidelberg DE Germany (DE) Universitätsklinikum Heidelberg DE Germany (DE) Brustkrebs Deutschland e.V. DE Germany (DE) atp Verlag GmbH DE Germany (DE) Universität Augsburg DE Germany (DE) Centrum für Hämatologie und Onkologie Bethanien DE Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden DE Germany (DE) Charité - Universitätsmedizin Berlin DE Germany (DE)

How to cite

APA:

Pixberg, C., Maurer, C., Smetanay, K., Straβl, L., Hlevnjak, M., Zapatka, M.,... Schneeweiss, A. (2025). COGNITION-GUIDE - Genomics-Guided Targeted Post-Neoadjuvant Therapy in Patients with Early Breast Cancer: Study Design of a Multicenter, Open-Label, Umbrella Phase II Study. Geburtshilfe und Frauenheilkunde. https://doi.org/10.1055/a-2557-1876

MLA:

Pixberg, Constantin, et al. "COGNITION-GUIDE - Genomics-Guided Targeted Post-Neoadjuvant Therapy in Patients with Early Breast Cancer: Study Design of a Multicenter, Open-Label, Umbrella Phase II Study." Geburtshilfe und Frauenheilkunde (2025).

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