COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer

Launched by GERMAN CANCER RESEARCH CENTER · Jun 14, 2023

Keywords

ClinConnect Summary

The COGNITION trial is studying how to better tailor treatments for patients with early-stage breast cancer who may not respond well to standard chemotherapy. Researchers are looking at tissue and blood samples from patients before and after their chemotherapy treatments to identify specific genetic markers. This information will help determine which patients might benefit from new, targeted therapies in a follow-up trial called COGNITION-GUIDE. The ultimate goal is to create a more personalized approach to treatment based on individual genetic profiles.

To be eligible for the trial, participants must be at least 18 years old and have early-stage breast cancer, regardless of its subtype. They can join the study either before starting chemotherapy, after completing it if they haven’t had a complete response, or after surgery if they meet certain criteria. Participants will be asked to provide a recent tumor sample for analysis. Throughout the trial, they can expect to receive close monitoring and care while contributing to important research that may improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Female and male breast cancer patients aged ≥18 years.
• • Patients with primary early breast cancer (irrespective of subtypes) or - as an exception - patients with isolated loco-regional relapses that can be treated with a curative intention
• * Study entry is possible for patients with primary eBC at three timepoints:
• • Option A: patients planned to receive neoadjuvant chemotherapy are enrolled before starting the neoadjuvant treatment
• • Option B: patients with clinical non-complete response can be enrolled after the last cycle of neoadjuvant chemotherapy before surgery Note: Option A/B are strongly preferred entry time-points
• • Option C: eBC patients after surgery and planned or conducting standard-of-care (SoC) post-neoadjuvant chemotherapy can be enrolled after surgery until the last cycle of standard post-neoadjuvant chemotherapy, if they fulfill the following criteria
• • HER2+ BC or TNBC: non-pCR
• • HR+/HER2- BC: non-pCR and CPS-EG score ≥ 3 or non-pCR, ypN+ and CPS-EG-score ≥ 2 Note: Option C is not the preferred entry time-point Note: in case of loco-regional relapse, neoadjuvant treatment is not mandatory
• • Patients must be willing to donate a recent tumour sample to the registry Note: fresh tumour tissue is preferred
• • Patients, who agreed to and were able to sign the informed consent form (ICF).
• Exclusion Criteria:
• • Patients who did not sign or withdrew the informed consent form (ICF).
• • Inability to retrieve tissue for molecular profiling Any physical or mental handicap or severe comorbidities that would hamper the adequate cooperation with the patient.