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RecruitingPHASE4INTERVENTIONAL

A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies

This study, called "A Study to Investigate Mechanisms of Resistance to Breast Cancer Therapies," aims to understand why breast cancer treatments sometimes stop working. We are inviting people with certain types of breast cancer (HER2-positive, hormone receptor-positive, or triple-negative) to take part. Researchers will collect small samples of their tumour tissue and blood. By studying these samples, we hope to discover the ways in which cancer cells learn to resist treatment. This knowledge is important because it could help doctors develop better treatments and find ways to overcome resistance in the future, ultimately improving care for people with breast cancer.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Hoffmann-La Roche
Enrolment target
320
Start
02 Apr 2024
Estimated completion
30 Sep 2026

What is this study about?

This research study is trying to understand a very important question: why do some breast cancer treatments stop working over time? Unfortunately, for many people with breast cancer, their treatment might work well for a while, but then the cancer starts to grow again. This is called 'treatment resistance'.

The study focuses on specific types of breast cancer: HER2-positive, hormone receptor-positive, and triple-negative breast cancer. Researchers believe that by looking closely at samples from patients, they can find clues about what changes happen in the cancer cells that make them resistant to treatment. They will examine both a small piece of the tumour (called a tissue sample) and a blood sample.

Learning why treatments stop working is crucial. Once we understand these 'resistance mechanisms', scientists can work on developing new medicines or new ways to use existing medicines to overcome this resistance. The goal is to make treatments more effective and last longer for people living with breast cancer.

Key takeaways

  • This study aims to understand why breast cancer treatments sometimes stop working.
  • It focuses on HER2-positive, hormone receptor-positive, and triple-negative breast cancer.
  • You would provide a tumour tissue sample and a blood sample.
  • Your participation could help develop better treatments for breast cancer patients in the future.
  • This study does not involve receiving new medications.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you would generally need to have been diagnosed with HER2-positive, hormone receptor-positive, or triple-negative breast cancer. The doctors would need to be able to safely take a small sample of your tumour (like a biopsy) and a blood sample. You also need to have some existing tumour tissue from a previous diagnosis available for the researchers to look at.

There are two main groups we are looking for. One group includes people whose cancer started to grow again after being on treatment for at least six months. The other group is for people whose cancer is still growing or getting worse even though they have been on treatment for at least four weeks but less than six months.

There are also some reasons why you might not be able to join. For example, if taking a tumour sample would be risky for you (like if you have a bleeding problem), or if you have another serious medical condition that would make it unsafe to take part. Also, if your cancer has already spread to your bones and that's the only place they could take a sample from, you wouldn't be able to join this particular study.

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.

  1. Do I have HER2-positive, hormone receptor-positive, or triple-negative breast cancer?
  2. Can a doctor safely take a small piece of my tumour?
  3. Has my cancer started to grow again recently, despite treatment?
  4. Am I at least 18 years old?
  5. Do I have some stored tumour tissue from a previous diagnosis?
  6. Am I well enough to have a small medical procedure?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main things you will need to do are:

Firstly, you’ll need to have a procedure to get a small sample of your tumour. This might be a biopsy, where a small piece of tissue is removed, or a slightly larger procedure, depending on what your doctor recommends and what is safest for you.

Secondly, you will have a blood sample taken.

Apart from these sample collections, the study team will also review your medical history and previous scan results. There are no new medications given as part of *this* study. This study is focused on collecting and analysing samples, not on testing new treatments. The exact duration of your involvement will depend on when the samples are collected, usually within four weeks of finishing your last anti-cancer treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For you, a direct benefit from taking part in *this* study isn't guaranteed, as it's not testing a new drug, but rather gathering information. However, your invaluable contribution will help researchers understand breast cancer better, potentially leading to improved treatments for others in the future. The main risks involve the procedure to obtain the tumour tissue, such as pain, bruising, or a small risk of bleeding or infection, similar to any biopsy procedure. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Institut Jules Bordet
    Verified postcode
    Anderlecht, Belgium· Recruiting
  • AZ KLINA
    Verified postcode
    Brasschaat, Belgium· Recruiting
  • CHU de Liège (Sart Tilman)
    Verified postcode
    Liège, Belgium· Recruiting
  • AZ Delta (Campus Rumbeke)
    Verified postcode
    Roeselare, Belgium· Recruiting
  • Aalborg Universitetshospital
    Verified postcode
    Aalborg, Denmark· Recruiting
  • Sjællands Universitetshospital, Næstved
    Verified postcode
    Næstved, Denmark· Recruiting
  • Helsinki University Central Hospital
    Verified postcode
    Helsinki, Finland· Recruiting
  • Tampere University Hospital
    Verified postcode
    Tampere, Finland· Recruiting
  • St. Elisabeth Krankenhaus Köln GmbH
    Verified postcode
    Cologne, Germany· Recruiting
  • KEM/Evang. Kliniken Essen Mitte gGmbH
    Verified postcode
    Essen, Germany· Recruiting
  • ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG
    Verified postcode
    Karlsruhe, Germany· Recruiting
  • Universitätsklinikum Mannheim
    Verified postcode
    Mannheim, Germany· Recruiting

Common questions

What kind of breast cancer do I need to have to join?

You need to have HER2-positive, hormone receptor-positive, or triple-negative breast cancer.

Will I get new medicine in this study?

No, this study is about collecting samples (tumour tissue and blood) to understand cancer, not about giving new treatments.

What is a 'biopsy'?

A biopsy is a procedure where a doctor takes a very small piece of your tissue, in this case, from your tumour, to examine it closely.

Will taking part affect my current breast cancer treatment?

No, taking part in this study should not affect your normal breast cancer care or treatment plan.

How long will I be involved in the study?

Your main involvement will be around the time of your tumour sample and blood draw, usually within four weeks of stopping your previous treatment.

How to find out more

Reference Study ID Number: WO44977 https://forpatients.roche.com/

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate Mechanisms of Resistance to Breast Ca…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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