CompletedInterventional

A study for women who have small breast cancers found by screening, comparing removal of the cancer by standard surgery with a smaller procedure, which is more like a biopsy

Routine breast screening often finds tiny, slow-growing cancers at an early stage. Usually, women have an operation to remove the lump, followed by treatments like radiotherapy and hormone tablets. While standard surgery works very well, it can leave scars, alter the shape of the breast, and take time to heal. The SMALL trial is testing whether a smaller, needle-guided procedure can safely replace standard surgery. This technique, called vacuum-assisted excision, gently removes the cancer through a tiny cut in the skin under local anaesthetic, similar to having a breast biopsy. Women who join are randomly chosen to have either standard surgery or the needle procedure. Everyone still receives standard follow-up treatments, including radiotherapy and hormone tablets. The aim is to find out if the gentler procedure protects against cancer returning just as effectively, while offering an easier recovery and better cosmetic results.

At a glance

Status

Completed

Sponsor

University of Birmingham

Enrolment target

800

Start

15 Nov 2019

Estimated completion

30 Jun 2026

Breast Cancer

What is this study about?

Breast screening mammograms are very good at finding cancers early, often when they are still tiny. Many of these screen-detected cancers are slow-growing and have a very low risk of spreading. At present, the standard NHS treatment is an operation called a lumpectomy or wide local excision. During this surgery, the surgeon removes the tumour along with a rim of healthy tissue around it.

Although standard surgery is very successful, doctors want to know if it might be more treatment than necessary for such small tumours. Surgery requires an incision that leaves a scar, can change the breast's appearance, and requires recovery time. Researchers created the SMALL trial to see if a minimally invasive procedure can achieve the same cancer-free results with fewer unwanted effects on the breast.

The trial compares standard surgery with a technique called vacuum-assisted excision (VAE). Instead of an operation under general anaesthetic, VAE is done using local anaesthetic to numb the area. A doctor uses ultrasound guidance to insert a small, hollow needle that gently vacuums out the lump in pieces. If the study shows this smaller procedure works just as well, it could save many women from having surgery in the future.

Key takeaways

The SMALL trial tests a needle-based procedure against standard surgery for tiny breast cancers found by screening.
It is open to women aged 47 and over with small, slow-growing, hormone-sensitive breast tumours.
Both groups receive standard radiotherapy and hormone tablets after the lump is removed.
The goal is to see if a smaller procedure can reduce scarring and recovery time without lowering cure rates.
Joining is completely voluntary, and you can change your mind at any stage.

Who may be eligible?

This trial is for women aged 47 and older who have had a very small breast cancer detected during routine breast screening. The tumour must be 15 millimetres or smaller (about the size of a small blueberry) and present in only one area of the breast. It must also be slow-growing, which doctors describe as 'Grade 1'.

To be eligible, the cancer cells must rely on female hormones to grow (strongly estrogen receptor positive and progesterone receptor positive) and must test negative for a growth protein called HER2. An ultrasound scan must show that the lymph nodes in the armpit are clear and healthy.

You cannot take part if you have previously had cancer in the same breast. You also need to be well enough, and willing, to have standard surgery if assigned to that group, and to receive standard post-procedure treatments such as radiotherapy and daily hormone tablets.

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 47 or older.
My breast cancer was found through routine breast screening.
My tumour is 15 millimetres or smaller and only in one spot.
My biopsy shows a slow-growing (Grade 1), hormone-positive, HER2-negative tumour.
My armpit lymph nodes are clear of cancer.
I am willing to have either standard surgery or the needle procedure, followed by radiotherapy and hormone tablets.

Answer every question to see your result.

What does participation involve?

If you decide to join the study, a computer will randomly place you into one of two groups. One group has standard breast-conserving surgery, while the other group has the vacuum-assisted needle procedure. The needle procedure is done as an outpatient visit under local anaesthetic and usually takes less than an hour. Afterwards, participants in both groups will receive standard breast cancer care, which typically includes a short course of radiotherapy and hormone tablets taken daily for five years. You will have regular hospital check-ups and yearly mammograms to check your breast health. Your overall follow-up in the study will last for several years.

Potential risks and benefits

The main benefit of taking part is helping doctors find kinder ways to treat early breast cancer. If you have the needle procedure, you may benefit from a quicker recovery, less bruising, and minimal scarring. However, there is a chance the needle procedure might not remove all the cancer cells; if this happens, you would need standard surgery afterwards. Both procedures carry small risks of bleeding, bruising, or wound infection. Taking part is entirely voluntary, and you can withdraw at any time without your regular NHS medical care being affected.

Locations (51)

Belfast City Hospital
Approximate
Belfast, Northern Ireland
Southmead Hospital
Approximate
Bristol, England
Addenbrookes Hospital
City only
Cambridge, England
Aberdeen Royal Infirmary
Approximate
Aberdeen, Scotland
Altnagelvin Area Hospital
City only
Londonderry, Northern Ireland
Edgware Community Hospital
Unverified
Edgware, England
Poole Hospital
Unverified
Poole, England
The Royal Marsden Hospital (surrey)
Unverified
Sutton, England
The Royal Victoria Infirmary
Unverified
Newcastle upon Tyne, England
Thomas Linacre Centre
Unverified
Wigan, England
Churchill Hospital
Unverified
Oxford, England
Craigavon Area Hospital
Unverified
Craigavon, Northern Ireland

Common questions

What is vacuum-assisted excision?

It is a gentle procedure where a doctor numbs your breast with local anaesthetic and uses a special hollow needle to remove the lump through a tiny cut, usually without needing stitches.

Will I still need radiotherapy and hormone tablets?

Yes. Both groups receive the usual standard treatments, including radiotherapy and hormone therapy, to give you the best protection against the cancer returning.

Can I choose which treatment I receive?

No. A computer randomly assigns you to either standard surgery or the needle procedure. This ensures the trial results are fair and reliable.

What happens if the needle procedure does not remove the whole lump?

The tissue removed is examined under a microscope. If any cancer cells remain around the edges, your doctor will arrange standard surgery to ensure everything is cleared.

Will joining the study change my NHS care?

No. You will continue to be cared for by your NHS breast care team, and you will receive close monitoring throughout the trial.

How to find out more

Jessica Foster

small@trials.bham.ac.uk +44 (0)121 414 3017 Official trial record

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