Active not recruitingOBSERVATIONAL

NOSTRA-Feasibility Study: A Study Looking at Ultrasound Guided Biopsies for Breast Cancer

This study, called NOSTRA-Feasibility, is exploring a new way to check for breast cancer remaining after chemotherapy and targeted drug treatment for a specific type of early breast cancer (HER2-positive, ER-negative). If there are still cancer cells, they're called 'residual cancer'. We want to see if taking several small tissue samples (biopsies) from the area where the tumour was, guided by ultrasound, can accurately tell us if all the cancer is gone. If these biopsies show no cancer, it might mean some patients could avoid surgery. This could potentially reduce the number of operations and recovery time for patients who have responded really well to their initial treatment. It's a first step to see if this method is safe and effective.

At a glance

Status

Active not recruiting

Sponsor

University of Birmingham

Enrolment target

Start

22 May 2019

Estimated completion

31 Dec 2025

Breast Cancer

What is this study about?

This study is called NOSTRA-Feasibility. It's looking into a new approach for women who have a specific type of early breast cancer. This type of cancer is called HER2-positive and ER-negative. You might have heard of these terms – they refer to certain features of the cancer cells that help doctors decide the best treatment. For this kind of cancer, patients usually receive chemotherapy alongside targeted treatments that specifically attack the HER2 protein on the cancer cells. This is given before any surgery and is called 'neoadjuvant treatment'.

The main aim of this study is to see if we can safely discover if any cancer cells are left after this initial treatment, without automatically needing surgery. Doctors will use ultrasound to guide them to the area where the tumour was. They will then take several tiny tissue samples, called 'core biopsies'. These samples will be carefully examined under a microscope by expert doctors (pathologists) to see if any cancer cells remain.

Currently, after chemotherapy and targeted treatment, most patients still have surgery. This study is a first step (a 'feasibility study') to find out if these special biopsies can accurately tell us if all the cancer has gone. If they can, it might mean that in the future, some patients could avoid surgery, which would mean fewer operations and a quicker recovery for those who respond very well to medication.

Key takeaways

Exploring a new way to check for cancer after initial treatment.
Aims to see if some patients with specific breast cancer could avoid surgery.
Uses ultrasound-guided biopsies to look for remaining cancer cells.
Applies to early-stage HER2-positive, ER-negative breast cancer.
Your routine medical care will not be affected by taking part.

Who may be eligible?

This study is for women aged 18 or older who have been diagnosed with a specific kind of early breast cancer. This cancer must be HER2-positive and ER-negative, and visible on an ultrasound scan. You would either be about to start treatment, or have started it recently (no more than five cycles of treatment approved for this study).

To be considered, you should be generally well enough for treatment, meaning you have a good 'performance status'. You also need to be able to safely receive the chemotherapy and targeted anti-HER2 treatments. You shouldn't have other serious health problems, such as certain heart conditions, uncontrolled high blood pressure, active bleeding issues, or another active cancer.

You cannot join if you've had invasive breast cancer or a certain type of pre-cancer (DCIS) in the same breast before, or if the cancer has spread to distant parts of your body. Also, if you're pregnant, breastfeeding, or have had certain vaccinations recently, you wouldn't be able to take part. The hospital team also needs to be able to perform the ultrasound-guided biopsies.

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 a woman aged 18 or over?
Have you been diagnosed with HER2-positive, ER-negative early breast cancer?
Is your tumour visible on an ultrasound scan?
Are you generally well and fit enough for cancer treatment?
Do you not have other serious health problems like certain heart conditions or another active cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main difference will be the additional ultrasound-guided biopsies. These biopsies will be taken from the area where your breast tumour was, after you've completed your initial chemotherapy and targeted treatment. The team needs to be confident they can safely perform these biopsies.

Doctors will carefully examine these biopsy samples to check for any remaining cancer cells. The study also wants to compare the findings from your local hospital with those from expert pathologists in a central lab. Your usual treatment with chemotherapy and targeted drugs will continue as planned. The total duration of your involvement will depend on your treatment schedule and follow-up, but the biopsy procedure itself is a one-off assessment.

Potential risks and benefits

Participating in this study might offer the potential benefit of contributing to new knowledge that could, in the future, help some women with breast cancer avoid surgery. For you personally, the main benefit is helping researchers understand if this new biopsy method is effective. The potential risks involve the biopsy procedure itself, such as pain, bruising, bleeding, or a small risk of infection, similar to any other biopsy. However, the procedures will be performed by experienced staff. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (24)

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

Basildon Hospital
Verified postcode
Basildon, United Kingdom
Belfast City Hospital
Verified postcode
Belfast, United Kingdom
City Hospital
Verified postcode
Birmingham, United Kingdom
Queen Elizabeth Hospital
Verified postcode
Birmingham, United Kingdom
Blackpool Teaching Hospitals NHS Trust
Verified postcode
Blackpool, United Kingdom
Southmead Hospital
Verified postcode
Bristol, United Kingdom
University Hospital of Llandough
Verified postcode
Cardiff, United Kingdom
Cheltenham General Hospital
Verified postcode
Cheltenham, United Kingdom
Dumfries and Galloway Royal Infirmary
Verified postcode
Dumfries, United Kingdom
Western General
Verified postcode
Edinburgh, United Kingdom
Northwick Park Hospital
Verified postcode
Harrow, United Kingdom
St James's University Hospital
Verified postcode
Leeds, United Kingdom

Common questions

What kind of cancer is this study for?

This study is for a specific type of early breast cancer that is HER2-positive and ER-negative.

What is 'neoadjuvant treatment'?

This is chemotherapy and targeted drugs given before surgery, to shrink the tumour.

What are 'tumour bed core biopsies'?

These are small tissue samples taken from the area where the tumour was, guided by ultrasound, to check for remaining cancer cells.

Why is this study important?

It could help doctors understand if some patients could safely avoid surgery after treatment if all their cancer is gone, potentially improving recovery.

Will I still get my regular cancer treatment?

Yes, your chemotherapy and targeted treatments will continue as planned.

How to find out more

Official trial record

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