Journal Article

DKFZ-2025-00897

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png 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. ; Straßl, L. ; Hlevnjak, M. ; Zapatka, M.DKFZ* ; Wagner, C. V. ; Yazdanparast, H. ; Kurzawa, J. ; Erben, V. ; Feng, F.DKFZ* ; Hong, C.DKFZ* ; Hübschmann, D.DKFZ* ; Buschhorn, L. ; Suppelna, J. P. ; Michel, L. ; Heublein, S. ; Fremd, C. ; Zivanovic, O. ; Sinn, P. ; Stenzinger, A. ; Haidinger, R. ; Schumacher-Wulf, E. ; Ditsch, N. ; Loibl, S. ; Fröhling, S.DKFZ* ; Link, T. ; Wimberger, P. ; Blohmer, J.-U. ; Huebner, H. ; Fasching, P. A. ; Janni, W. ; Schlenk, R. F. ; Thewes, V. ; Lichter, P. (Last author)DKFZ* ; Schneeweiss, A.

2025
Thieme New York, NY

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Please use a persistent id in citations: 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.

Note: #LA:B060# / 2025 Apr 10;85(6):611-619

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Contributing Institute(s):

1. B060 Molekulare Genetik (B060)
2. Translationale Medizinische Onkologie (B340)
3. DKTK HD zentral (HD01)

Research Program(s):

1. 312 - Funktionelle und strukturelle Genomforschung (POF4-312) (POF4-312)

Appears in the scientific report 2025

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Database coverage:
; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Essential Science Indicators ; IF < 5 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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