Genomics-guided precision oncology for early high-risk breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COGNITION platform focuses on understanding the biomarker profiles of tumors in patients with early-stage breast cancer who do not respond well to standard neoadjuvant chemotherapy. It involves collecting tissue and blood samples from patients to perform comprehensive genomic profiling, which helps identify those who may benefit from targeted therapies in a subsequent interventional trial. The study aims to create a robust database for biomarker screening and stratification to improve treatment outcomes. This approach integrates genomic data with clinical information to guide personalized treatment strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Augsburg
  Augsburg, Germany Recruiting
• Charité - Berlin
  Berlin, Germany Recruiting
• University Hospital Köln
  Cologne, Germany Recruiting
• Medical Faculty and University Hospital Carl Gustav Carus
  Dresden, Germany Recruiting
• University Hospital Erlangen
  Erlangen, Germany Recruiting
• National Center for Tumor Diseases (NCT) Heidelberg
  Heidelberg, Germany Recruiting

Study contacts

• Principal investigator: Peter Lichter, PhD — German Cancer Research Center (DKFZ) Heidelberg
• Study coordinator: Andreas Schneeweiss, MD
• Email: Andreas.Schneeweiss@med.uni-heidelberg.de
• Phone: 0049-6221-5636051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.