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Breast Cancer's genetic fingerprint: a new platform aims to match tumors to targeted trials

NCT ID NCT05906407

Diagnosis Sponsor: German Cancer Research Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

The COGNITION study is a molecular diagnostic platform that collects tumor and blood samples from up to 2,000 adults with early breast cancer, including those receiving chemotherapy before surgery. Researchers perform comprehensive genomic sequencing on samples taken before and after treatment to identify biomarkers that may guide future therapy. The goal is to build a database that helps match patients to biomarker-driven clinical trials, such as the related COGNITION-GUIDE study. This is an observational registry, not a treatment trial, so participants do not receive experimental therapies as part of this study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
genomic profiling of tumor and blood samples
What this could lead to
If it works, this platform could help doctors match early breast cancer patients to treatments based on the specific molecular features of their tumors, moving precision oncology closer to routine care.
What could go wrong
This is a diagnostic registry, not a treatment trial, so it will not directly cure anyone. Genomic profiling may not find actionable biomarkers for every patient, and the platform's success depends on enough patients enrolling in follow-up therapy trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

High-risk early-stage breast cancer (eBC) with suspected (non-clinical Complete Response - non-cCR ) and/or proven (non-pathological Complete Response - non-pCR) poor response towards NACT (irrespective of subtype).

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early-stage breast cancer Neoadjuvant therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Caritas Hospital St. Josef

    RECRUITING

    Regensburg, Germany

  • Charité - Berlin

    RECRUITING

    Berlin, Germany

  • Medical Faculty and University Hospital Carl Gustav Carus

    RECRUITING

    Dresden, Germany

  • National Center for Tumor Diseases (NCT) Heidelberg

    RECRUITING

    Heidelberg, Germany

  • Robert Bosch Hospital Stuttgart

    RECRUITING

    Stuttgart, Germany

  • University Hospital Augsburg

    RECRUITING

    Augsburg, Germany

  • University Hospital Erlangen

    RECRUITING

    Erlangen, Germany

  • University Hospital Essen

    NOT_YET_RECRUITING

    Essen, Germany

  • University Hospital Köln

    RECRUITING

    Cologne, Germany

  • University Hospital Tübingen

    RECRUITING

    Tübingen, Germany

  • University Hospital Ulm

    RECRUITING

    Ulm, Germany

  • University Hospital Würzburg

    RECRUITING

    Würzburg, Germany

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