CompletedObservational

Can patients with residual cancer after chemotherapy for early breast cancer be identified with multiple ultrasound-guided biopsies?

Certain treatments for breast cancer work so well that the tumour completely disappears before an operation takes place. This trial, called NOSTRA, is testing whether doctors can confirm this using ultrasound-guided needle biopsies. The study focuses on women with early-stage, HER2-positive, ER-negative breast cancer who receive targeted chemotherapy before surgery. Currently, an operation is always needed to remove tissue and check if any cancer cells remain. In this study, doctors take several small tissue samples (biopsies) from the area where the tumour was after chemotherapy finishes. Everyone in the trial will still have their planned surgery. Researchers will compare the biopsy results with the surgical results to see how accurate the biopsies were. If successful, this research could pave the way for future studies exploring whether some patients could safely skip breast surgery altogether.

At a glance

Status

Completed

Sponsor

University of Birmingham

Enrolment target

150

Start

31 Jan 2019

Estimated completion

31 Dec 2023

Breast cancer

What is this study about?

Many people with HER2-positive breast cancer receive chemotherapy along with targeted medicines before having an operation. This is called neoadjuvant treatment. In many cases, these powerful modern drugs clear away all the cancer cells in the breast before the surgeon ever operates.

Even when scans show that the tumour seems to have gone, surgeons still perform an operation. At present, surgery is the only reliable way to check the tissue under a microscope and prove that no cancer cells remain. The NOSTRA study aims to find out if several small tissue samples—known as core biopsies—taken using an ultrasound scan can accurately detect whether any microscopic cancer is left behind.

Because this is a feasibility study, all participants will still have their planned breast surgery after the biopsies. Pathologists will then compare the tissue taken during the ultrasound biopsies with the larger tissue sample removed during surgery. If the biopsies prove to be just as accurate as surgery at spotting leftover cancer, it could lead to future trials where surgery might safely be avoided for some patients.

Key takeaways

The NOSTRA study tests whether multiple needle biopsies can detect leftover breast cancer after chemotherapy.
It is designed for women with early-stage, HER2-positive, ER-negative breast cancer.
All participants will still have their standard breast cancer surgery.
The findings could help doctors design future trials to see if some patients can safely skip surgery.
Taking part is voluntary and will not delay your planned cancer treatments.

Who may be eligible?

This study is open to women aged 18 and over who have been diagnosed with early-stage, HER2-positive and ER-negative invasive breast cancer. The breast tumour must be at least 1 centimetre across and clearly visible on an ultrasound scan. Participants should also be generally well and able to carry out day-to-day activities.

To take part, you must be well enough to have the standard chemotherapy medicines used in the trial. Women who could become pregnant must be willing to use effective birth control during treatment and for at least six months afterwards. There is also an optional part of the study looking at blood markers, which requires blood samples before chemotherapy begins.

You will not be able to join if you have previously had breast cancer or pre-cancerous cells (DCIS) in the same breast, or if your cancer has spread to other distant parts of the body.

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.

I am a woman aged 18 or older.
I have been diagnosed with early-stage HER2-positive, ER-negative breast cancer.
My breast tumour is at least 1 centimetre in size and can be seen on an ultrasound scan.
I have not had breast cancer or DCIS in this same breast before.
The cancer has not spread to other distant parts of my body.

Answer every question to see your result.

What does participation involve?

Taking part in this study fits closely around standard breast cancer care. You will first receive standard chemotherapy combined with targeted drugs over several months to shrink the tumour. Once your chemotherapy is finished, but before your planned surgery, you will attend a hospital visit for the study procedure. During this visit, a doctor will use an ultrasound scan to guide a needle and take several small core biopsies from the area where your tumour was. You will then have your standard breast surgery as scheduled, usually a few weeks later. If you join the blood-testing sub-study, you will also give blood samples before your chemotherapy starts and at planned clinic visits. Your overall care, recovery, and regular hospital follow-ups will continue as normal through your standard NHS breast cancer team.

Potential risks and benefits

Taking part in this trial may not directly improve your personal health outcome, as you will still have standard chemotherapy and surgery. However, you will have extra monitoring, and your participation could help future breast cancer patients avoid unnecessary operations. The main risks involve the extra biopsies, which can cause brief discomfort, bruising, mild bleeding, or a small risk of infection at the needle site. Local anaesthetic is used to keep you comfortable during the procedure. You also face the normal side effects of chemotherapy, which your doctor will explain in detail. Joining the study is completely voluntary, and you are free to withdraw at any time without your regular care being affected.

Locations (24)

Singleton Hospital
Approximate
Swansea, Wales
Basildon
Approximate
Basildon, England
Borders General Hospital
City only
Melrose, Scotland
Belfast City Hospital
Approximate
Belfast, Northern Ireland
Dumfries and Galloway Royal Infirmary
Approximate
Dumfries, Scotland
Llandough Hospital
Unverified
Penarth, Wales
Cheltenham General Hospital
Unverified
Cheltenham, England
Nottingham City Hospital
Unverified
Nottingham, England
Northwick Park Hospital
Unverified
Harrow, England
Queen Elizabeth Hospital Birmingham
Unverified
Birmingham, England
Peterborough City Hospital
Unverified
Peterborough, England
Royal Victoria Infirmary
Unverified
Newcastle upon Tyne, England

Common questions

Will taking part allow me to avoid having breast surgery?

No. Because this is an early research study, every participant will still have their planned breast surgery. The biopsies are being tested to see if they are accurate enough to consider avoiding surgery in future studies.

What does an ultrasound-guided biopsy feel like?

The doctor numbs the skin and deeper breast tissue with a local anaesthetic first. You may feel a brief sting from the numbing injection and some pressure during the biopsy, but it is usually not painful.

What is the blood test (ctDNA) sub-study?

This is an optional part of the trial that checks whether tiny fragments of tumour DNA can be detected in your bloodstream. It requires a few extra blood samples taken alongside your routine clinic visits.

Will this trial delay my cancer treatment?

No. The study procedures are planned carefully around your normal chemotherapy and surgery schedule to ensure there are no unsafe delays to your treatment.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point. Your decision will not affect your standard NHS treatment, and your medical team will continue to look after you as normal.

How to find out more

Elizabeth Southgate

Nostra@trials.bham.ac.uk +44 (0)121 414 3604 Official trial record

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