COGNITION-GUIDE - Genomics-Guided Targeted Post-Neoadjuvant Therapy in Patients with Early Breast Cancer: Study...

Area of Science:

• Oncology
• Genomics
• Clinical Trials

Background:

• Early breast cancer (eBC) patients often remain at high risk for relapse after neoadjuvant therapy (NAT).
• Residual tumor analysis via next-generation sequencing (NGS) identifies biomarkers and actionable alterations in high-risk eBC.
• This stratification aims to guide subsequent therapies, reducing metastatic risk and improving disease-free survival.

Purpose of the Study:

• To translate molecular biomarker profiles into targeted post-neoadjuvant therapeutic options.
• To evaluate the efficacy of a biomarker-guided therapy escalation algorithm in high-risk eBC.
• To improve invasive disease-free survival (IDFS) in early breast cancer patients.

Main Methods:

• The COGNITION-GUIDE is a multicenter, umbrella phase-II trial.
• Patients receive molecular-guided therapies (e.g., PD-L1, PI3K, AKT, PARP, Trop-2, HER2 inhibition) or observation based on biomarker profiles.
• The primary endpoint is IDFS at four years post-surgery, with secondary endpoints including distant disease-free survival, overall survival, and safety. 240 patients will be enrolled.

Main Results:

• N/A - Trial results are pending as the trial was activated in June 2023.

Conclusions:

• The COGNITION-GUIDE trial implements a risk-adapted, biomarker-guided therapy escalation strategy for eBC.
• This approach targets patients with early breast cancer who have a high risk of metastasis after neoadjuvant therapy.
• The trial aims to personalize treatment based on molecular profiles to enhance outcomes.