RecruitingOBSERVATIONAL

Prospective Evaluation of AI R&D Tool for Patient Stratification - MoA Evaluation in Triple Negative Breast Cancer (PEAR-MET)

This study, called PEAR-MET, is for people with advanced triple-negative breast cancer. Researchers are testing a new device that uses a tiny piece of your tumour to predict which treatments might work best. This device, called an "organ-on-a-chip," helps scientists understand how your specific cancer cells react to different medicines in a lab setting. While you receive your regular treatment, the study will run tests on your tumour sample. Your doctor won't see these test results during your treatment. The main goal is to find out how accurate this new tool is at predicting how well a treatment works for you, and if it can help patients live longer and have their cancer under control for longer.

At a glance

Status

Recruiting

Sponsor

Ourotech, Inc.

Enrolment target

Start

30 Apr 2024

Estimated completion

30 Jun 2026

Breast Cancer Triple Negative Breast Cancer

What is this study about?

This study is looking into a new way to understand and treat advanced triple-negative breast cancer. This type of cancer can be challenging to treat because it doesn't respond to some common cancer medicines. Researchers at Pear Bio have created a special tool that's like a tiny lab dish, called an "organ-on-a-chip." This device can grow a small part of your tumour and test how it reacts to different cancer drugs. The idea is to find out, in advance, which treatments might be most effective for your specific cancer.

For this study, if you have advanced triple-negative breast cancer and are about to start a new treatment, you might be asked to take part. Doctors will take a small sample of your tumour (a biopsy) and a blood sample. These samples will be used with the new Pear Bio tool. While you are undergoing your regular cancer treatment decided by your doctor, the tool will be running tests in the lab. Your doctor won't know the results from the new tool during your treatment, so it won't change your current care.

The main purpose of this study is to see how well this new tool predicts how you respond to your treatment. Researchers want to know if the tool accurately shows which treatments will work, help control the cancer, and potentially help patients live longer. Ultimately, the hope is that this new technology could, in the future, help doctors choose the best possible treatment for each individual with triple-negative breast cancer.

Key takeaways

This study is testing a new way to predict which treatments work best for advanced triple-negative breast cancer.
It uses a small sample of your tumour on an 'organ-on-a-chip' device.
Your doctor will continue your regular treatment, unaffected by the study tests.
Participating may help improve future treatments for triple-negative breast cancer.
You will need to have a biopsy and blood test for the study.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with triple-negative breast cancer that has either spread (advanced) or come back (metastatic). You should be planning to start a new course of treatment soon, or have already had some treatment and are about to try another.

To join, you'll need to have a small tissue sample taken from your tumour (a biopsy) and give a blood sample specifically for the study. It's important that your cancer is confirmed as triple-negative, and that you are not receiving experimental treatments that are not part of the study's plan.

You cannot take part if your cancer is not triple-negative, or if it was found at a very early stage. You also can't join if you don't plan to have systemic therapy (treatment that goes through your whole body, like chemotherapy), or if you've already started a new treatment and won't be having any changes to it after providing the study samples.

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 advanced or metastatic triple-negative breast cancer?
Are you about to start a new course of treatment?
Are you willing and able to have a small tumour biopsy and give a blood sample for the study?
Are you NOT currently receiving treatments that are considered experimental or outside of standard care?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll need to do is have a small tissue sample taken from your breast tumour or a place where the cancer has spread. This is called a core needle biopsy, and it will be done before you start your next course of cancer treatment. You'll also need to give a blood sample, about 40ml (which is about 8 teaspoons).

After these samples are collected, you will continue with your regular cancer treatment as decided by your doctor. The study tests will happen in the background using your samples. Your doctors involved in your treatment won't see the results from these study tests until much later, as the aim is to check how well the new tool works compared to your actual treatment outcome.

Throughout your treatment, information about how your cancer responds will be collected from your medical records at different times. The total duration of your involvement will depend on how long information is gathered about your treatment response, but the main sample collection is done at the beginning.

Potential risks and benefits

Taking part in this study won't directly change your current medical care, as your doctors won't see the test results from the new tool during your treatment. However, by participating, you could help researchers learn more about triple-negative breast cancer and how to find the best treatments for it. This knowledge could help future patients. The main risks involve the biopsy and blood draw, which can cause some discomfort, bruising, or a small risk of infection, as with any medical procedure. You are free to withdraw from the study at any time without explaining why, and this will not affect your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Barts Hospital NHS Trust
Verified postcode
London, United Kingdom· Recruiting
Guys and St. Thomas Hospital NHS Trust
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is triple-negative breast cancer?

Triple-negative breast cancer is a type of breast cancer that doesn't have the receptors (special proteins) that some common cancer medicines target. This means it needs different treatment approaches.

What is an 'organ-on-a-chip'?

It's a tiny device that can grow a small part of your tumour cells in a lab. It helps scientists test how these cells react to different drugs, like having a tiny, personalised lab for your cancer.

Will this study change my treatment?

No, this study will not change your current treatment plan. Your doctor will make all decisions about your treatment based on standard care. The study tests are run separately.

What is a biopsy?

A biopsy is a procedure where a small sample of tissue is taken from your body, often using a needle. In this study, it's to get a piece of your tumour for testing.

How long will I be involved in the study?

Your main involvement will be at the beginning to provide the biopsy and blood samples. After that, information about your treatment will be collected from your medical records over time.

How to find out more

Duleek Ranatunga

duleek@pearbio.com +44 7716558079 Official trial record

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