RecruitingOBSERVATIONAL

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

The COGNITION study is looking into why some early-stage breast cancers don't respond well to standard chemotherapy before surgery. Researchers analyse tumour and blood samples from patients to identify unique patterns, or 'biomarkers', in their cancer. This helps them understand what drives the cancer and find better ways to treat it. The main goal is to create a system that can accurately group patients based on these biomarkers, guiding them towards more personalised treatments in a linked study called COGNITION-GUIDE. This approach, known as 'precision oncology', aims to make future treatments more effective by tailoring them to each person's specific cancer, rather than using a one-size-fits-all approach.

At a glance

Status

Recruiting

Sponsor

German Cancer Research Center

Enrolment target

2,000

Start

19 Apr 2019

Estimated completion

31 Dec 2028

Early-Stage Breast Cancer Neoadjuvant Therapy

What is this study about?

The COGNITION study is focused on people who have early breast cancer. Sometimes, before surgery, patients are given chemotherapy to shrink the tumour. This is called 'neoadjuvant therapy'. For some people, this standard chemotherapy doesn't work as well as hoped, and some cancer cells are left behind.

This study wants to find out why this happens. Researchers will collect tumour samples (from before and after chemotherapy) and blood samples. They will then look very closely at these samples using special tests to understand the unique characteristics of each person's cancer. They're looking for specific 'biomarkers' – these are like unique fingerprints of your cancer that can tell doctors how it might behave and what treatments might work best. By understanding these biomarkers, the study hopes to find new and more effective ways to treat breast cancer, especially for those cases that are harder to treat.

Ultimately, the information gathered from this study will help develop a new system for 'precision oncology'. This means finding the right treatment for the right person at the right time. The findings from COGNITION will guide another study, called COGNITION-GUIDE, which will test these tailored treatments. This could lead to more personalised and successful treatments for breast cancer patients in the future.

Key takeaways

This study aims to find better ways to treat breast cancer, especially if it doesn't fully respond to standard chemotherapy.
Researchers will look at tumour and blood samples to understand each person's unique cancer.
The goal is to develop more personalised and effective treatments for the future.
This is an observational study, meaning it won't change your current medical care.
Participation involves providing tissue and blood samples during your existing treatment journey.

Who may be eligible?

This study is for adults aged 18 and over, both men and women, who have early breast cancer. You might also be eligible if your cancer has come back only in the local area and can still be treated with the aim of curing it.

You can join at different stages: either before you start your chemotherapy given before surgery, after this chemotherapy but before surgery if it didn't completely remove the cancer, or even after surgery if some cancer was still present and you're having follow-up chemotherapy. The key requirement is that you are willing to provide a sample of your tumour tissue.

However, you cannot take part if you haven't given your written permission to join, or if medical staff can't get a tumour sample from you. Also, if you have any serious health problems or difficulties that would prevent you from taking part safely, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have early breast cancer or have breast cancer that has returned only in the local area?
Are you willing to provide samples of your tumour tissue?
Are you able to give your informed consent (permission) to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in COGNITION, it would involve giving some extra tumour tissue samples during your usual procedures (once before chemotherapy and once after, if there's any remaining tumour after treatment). You would also provide blood samples at two points in time. There aren't any extra doctor visits or changes to your standard treatment schedule specifically for this study. The main focus is on collecting and analysing these samples to understand your cancer better. Your participation helps researchers learn more, but it doesn't involve new medications directly within this COGNITION study. The overall duration of your involvement in this part of the research would depend on your treatment timeline for breast cancer.

Potential risks and benefits

Taking part in this study won't change your standard medical care, and there aren't any new drugs or treatments given directly as part of COGNITION. The main benefit is that your information could help researchers better understand breast cancer and develop more targeted treatments for others in the future. The risks largely relate to the sample collection, which are the same as those for routine medical procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

University Hospital Augsburg
Verified postcode
Augsburg, Germany· Recruiting
Charité - Berlin
Verified postcode
Berlin, Germany· Recruiting
University Hospital Köln
Verified postcode
Cologne, Germany· Not yet recruiting
Medical Faculty and University Hospital Carl Gustav Carus
Verified postcode
Dresden, Germany· Recruiting
University Hospital Erlangen
Verified postcode
Erlangen, Germany· Recruiting
University Hospital Essen
Verified postcode
Essen, Germany· Not yet recruiting
National Center for Tumor Diseases (NCT) Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
Caritas Hospital St. Josef
Verified postcode
Regensburg, Germany· Recruiting
Robert Bosch Hospital Stuttgart
Verified postcode
Stuttgart, Germany· Recruiting
University Hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting
University Hospital Ulm
Verified postcode
Ulm, Germany· Recruiting
University Hospital Würzburg
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What is 'early breast cancer'?

Early breast cancer means the cancer hasn't spread beyond the breast or nearby lymph nodes.

What is 'neoadjuvant chemotherapy'?

This is chemotherapy given before surgery to shrink the tumour and make surgery easier.

What are 'biomarkers'?

Biomarkers are tiny clues in your body or cancer cells that can help doctors understand your cancer and how it might respond to treatments.

Will this study change my current treatment?

No, this study mainly collects and analyses samples; it doesn't change your planned cancer treatment directly.

What is 'precision oncology'?

Precision oncology is about tailoring cancer treatments to each person based on the unique genetic make-up of their tumour.

How to find out more

Andreas Schneeweiss, MD

andreas.schneeweiss@med.uni-heidelberg.de 0049-6221-5636051 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.