COGNITION-GUIDE

Gynecological tumors / Breast cancer
Breast cancer
Neoadjuvant Therapy
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Eligible patients are identified considering pCR-status and clinical stage estrogen receptor status grade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy- arms is conducted by a molecular tumor board based on in depth molecular characterization of tumors within the COGNITION registry program. Recruitment of adequate patient numbers in well-defined molecular subgroups is achieved in a multicenter approach. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.
The trial evaluates not a single drug but rather a general strategy of precision oncology in the curative setting and provides the basis for future confirmatory biomarker-driven trials. Eligible patients are identified considering pCR-status and clinical stage estrogen receptor status grade (CPS-EG)-score following surgery after neoadjuvant therapy. Allocation to the therapy- arms is conducted by a molecular tumor board based on in depth molecular characterization of tumors within the COGNITION registry program. Recruitment of adequate patient numbers in well-defined molecular subgroups is achieved in a multicenter approach. The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of each study-arm. The primary endpoint of the study is invasive Disease-Free Survival (IDFS) after 4 years measured from surgery to local or distant relapse or death. The sample size of the entire trial is 240 eligible patients.