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Breast Cancer Evolution During Neoadjuvant Systemic Therapy

The BELIEVE study is looking at breast cancer in people having treatment before surgery. Researchers collect tissue samples, blood, and sometimes MRI scans and stool samples. They want to understand why some breast cancers respond better to treatments like chemotherapy, targeted therapy, or immunotherapy than others. By studying these samples, they hope to find new ways to accurately check if a treatment is working during the process. Another key aim is to identify which patients might be at a higher risk of their cancer coming back after surgery. Ultimately, this research aims to improve how breast cancer is treated in the future and make treatments more effective for everyone.

At a glance

Status
Recruiting
Sponsor
Royal Marsden NHS Foundation Trust
Enrolment target
500
Start
29 May 2024
Estimated completion
01 May 2034

What is this study about?

Breast cancer is a common illness in the UK, and while treatments have improved a lot, it sadly still causes many deaths. Doctors often give medicines like chemotherapy, targeted therapy, or immunotherapy (these are called 'systemic treatments') before surgery for more aggressive or advanced breast cancers. Giving these treatments first, known as 'neoadjuvant therapy', can help shrink the cancer, making it easier to remove with less intensive surgery.

Doctors have learned that how much the cancer shrinks or responds to these treatments before surgery is a very important sign. If a lot of cancer is still present at the time of surgery, it means there's a higher chance the cancer might come back later. This study, called BELIEVE, wants to understand why some cancers respond really well to these pre-surgery treatments, and others don't.

By carefully looking at samples of cancer tissue, blood, and sometimes stool, along with MRI scan results, the researchers hope to find clues. They want to discover specific things about either the patient or their cancer that could help predict if a treatment will work, and also track if it *is* working during the treatment. The goal is to put all this information together to develop better ways to predict who will respond well, who might need a different treatment, and who is at higher risk of their cancer returning, ultimately leading to more personalised and effective care for breast cancer patients.

Key takeaways

  • The BELIEVE study aims to improve understanding of breast cancer treatment.
  • It collects samples (tissue, blood, sometimes stool) and MRI data.
  • Focuses on treatments given *before* surgery (neoadjuvant therapy).
  • Hopes to predict how well treatments work and if cancer might return.
  • This research does not involve new treatments for participants.

Who may be eligible?

To take part in this study, you would need to have breast cancer that hasn't spread to other parts of your body. You should also be planning to start treatments like chemotherapy, targeted therapy, or immunotherapy *before* having surgery for your breast cancer, and not have started them yet. If you have HER2-positive breast cancer, you should be suitable for treatment that targets HER2.

You must be 18 years old or older and willing to give your written permission to join the study.

However, you cannot join if your breast cancer has already spread to other parts of your body when it was diagnosed, or if your planned treatment before surgery is only hormone therapy. Also, if there are any personal circumstances that might make it difficult for you to follow the study plan and attend follow-up appointments, you might not be able to participate.

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. My breast cancer has not spread to other parts of my body.
  2. I am planning to start chemotherapy, targeted therapy, or immunotherapy before my breast cancer surgery (and haven't started yet).
  3. I am 18 years old or older.
  4. I am comfortable providing blood and tissue samples, and possibly stool samples.
Answer every question to see your result.

What does participation involve?

This study involves collecting samples at different times during your breast cancer treatment before surgery. You would provide samples of your breast cancer tissue (usually taken during routine biopsies) and blood samples. In some cases, you might also have MRI scans and provide stool (poo) samples. These samples would be collected before you start your treatment and then again at certain points while you are receiving your treatment before surgery. The study primarily uses samples and information gathered as part of your normal care plan, but with additional collection points for research. The total duration of your participation would align with your pre-surgery treatment period and follow-up for sample collection, which your doctor can explain in more detail.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of breast cancer and its response to treatments, which could help improve future care for others. You will not personally receive any new treatment as part of this study, nor will your immediate care change. The main 'risk' would be the discomfort associated with additional blood draws or sample collections beyond your standard care. However, efforts are made to minimise any extra procedures. You are always free to withdraw from the study at any time without affecting your medical treatment or care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Marsden NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is 'neoadjuvant therapy'?

It's a medical term for treatments like chemotherapy or targeted therapy given before surgery to shrink the cancer.

Will I get a new treatment in this study?

No, this study is about collecting samples and information from treatments you're already receiving, not giving new medicines.

What kind of samples will be collected?

Researchers will collect breast cancer tissue, blood, and sometimes MRI scans and stool (poo) samples.

How will this study help breast cancer patients?

It aims to help doctors understand why treatments work for some and not others, leading to better-tailored treatments in the future.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect your medical care.

How to find out more

BELIEVE Trial Manager

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 "Breast Cancer Evolution During Neoadjuvant Systemic Therapy…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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