Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)
Status:
Not yet recruiting
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
Summary
In early breast cancer (eBC), pathological complete response (pCR) after neoadjuvant therapy
acts as surrogate marker for metastasis and overall survival. Therapy intensification by
adding an adjuvant therapy line (post-neoadjuvant treatment) substantially lowers the risk of
relapse in high-risk breast cancer patients with residual disease after neoadjuvant treatment
(non-pCR). While this approach was exemplified in two phase III trials without
biomarker-stratification (CREATE-X, KATHERINE), even higher efficiency might be achieved by
individualized genomic-guided post-neoadjuvant therapies.
Within the seven-arm umbrella phase-II clinical trial COGNITION-GUIDE, we aim to deliver
molecularly-tailored cancer care by implementing an additional response- and genomics-guided
post-neoadjuvant therapy after finishing the guideline-compliant post-neoadjuvant treatment
in high-risk breast cancer patients with residual cancer burden after neoadjuvant therapy to
reduce the substantial risk of local and distant relapse.
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.
Allocation to the therapy-arms is conducted by in depth molecular characterization of tumors
within the COGNITION registry program.
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.