Genomics-guided precision oncology for early high-risk breast cancer
COGNITION: Comprehensive Assessment of Clinical Features, Genomics and Further Molecular Markers to Identify Patients with Early Breast Cancer for Enrolment on Marker Driven Trials (Molecular Diagnostic Platform)
German Cancer Research Center · NCT05906407
This study is testing if analyzing the genes of early-stage breast cancer tumors can help find better treatment options for patients who don't respond well to standard chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | German Cancer Research Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Augsburg and 11 other locations) |
| Trial ID | NCT05906407 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed early breast cancer who are scheduled to receive neoadjuvant chemotherapy or those with isolated loco-regional relapses.
Not a fit: Patients who have not been diagnosed with early breast cancer or those who do not require neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatment options for patients with early high-risk breast cancer.
How similar studies have performed: Other studies utilizing genomic profiling in breast cancer have shown promise, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Augsburg and 11 other locations
- University Hospital Augsburg — Augsburg, Germany (RECRUITING)
- Charité - Berlin — Berlin, Germany (RECRUITING)
- University Hospital Köln — Cologne, Germany (NOT_YET_RECRUITING)
- Medical Faculty and University Hospital Carl Gustav Carus — Dresden, Germany (RECRUITING)
- University Hospital Erlangen — Erlangen, Germany (RECRUITING)
- University Hospital Essen — Essen, Germany (NOT_YET_RECRUITING)
- National Center for Tumor Diseases (NCT) Heidelberg — Heidelberg, Germany (RECRUITING)
- Caritas Hospital St. Josef — Regensburg, Germany (RECRUITING)
- Robert Bosch Hospital Stuttgart — Stuttgart, Germany (RECRUITING)
- University Hospital Tübingen — Tübingen, Germany (RECRUITING)
- University Hospital Ulm — Ulm, Germany (RECRUITING)
- University Hospital Würzburg — Würzburg, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early-Stage Breast Cancer, Neoadjuvant Therapy, Early Breast Cancer, Precision Oncology, Personalized Oncology, Genomic Profiling, Genomics-Guided Biomarker-Stratification, Postneoadjuvant-Therapy