
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."
This trial is comparing surgery with vacuum assisted excision for small early breast cancers.
It is for women taking part in the NHS breast screening programme. And who had a small found during their screening.
One of the for breast cancer is surgery even if it is a small breast cancer. But for women with a small cancer this might be more treatment than is necessary.
Researchers think that vacuum assisted excision might be as good as surgery for women with a small breast cancer.
Vacuum assisted excision (VAE) uses a needle inserted into your breast. Attached to the needle is a vacuum device that sucks out the cancer. VAE is already used to take out lumps in the breast that aren’t cancer ().
In this trial researchers want to compare VAE to surgery. The aims are to find out:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You are a woman and you:
Who can’t take part
You cannot join this trial if any of these apply. You:
This is a phase 3 trial. The team need 800 women to take part.
It is a randomised trial. There are 2 groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:
Two out of every 3 women who join go into the VAE group and 1 in 3 go into the surgery group.
Vacuum assisted excision (VAE)You have an injection of just under the skin where the lump is. This stings a bit as the anaesthetic goes in. The anaesthetic numbs the area.
The doctor uses or mammogram to guide where to put the biopsy needle. When the needle is in place they use suction to remove the lump. The needle stays in place during the whole procedure. During the procedure you might hear a small noise. But you shouldn’t feel any discomfort.
After removing the lump the doctor puts a small metal clip in place where the lump was. This stays in your breast and won’t cause you any problems.
After the VAE you have a mammogram to make sure the operation removed all the lump. You might need to have another mammogram about 4 weeks later if the first showed there was bruising in the breast. If there is concern that any of the cancer might be left when you have your mammogram, you may need to have an operation.
You will continue treatment after VAE with radiotherapy and hormone therapy. Your doctor will talk to you about this.
The doctor sends the tissue to the lab for investigations. You see the doctor in clinic when the results are back.
You might need to have an operation if the results worry the doctor. For example the cancer might be faster growing than first thought. Your doctor will talk to you about this.
Surgery
You have an operation under a general anaesthetic to have your lump removed. This is a wide local excision (lumpectomy).
Because the lump is small you might have an ultrasound or mammogram before surgery to locate where the lump is. This so the surgeon knows where the lump is and can remove it all.
You also have 1 or 2 lymph nodes in your armpit (axilla) removed. This is a biopsy.
During the operation the surgeon places metal clips in the breast where the lump was. These stay in your breast and won’t cause you any problems.
The surgeon sends the tissue they remove to the lab for investigations. You see the doctor in clinic about 10 to 14 days after surgery. This is to tell you the results of the lab investigations. They will also tell you whether the operation removed all the cancer. You might need another operation if all of the cancer wasn’t removed.
At this appointment your doctor will also talk about any further treatment you might need. This might include hormone therapy and radiotherapy.
Information study
As part of the SMALL study the researchers want to find more about how:
This means the team are asking some people if they can record all the phone calls and face to face appointments they have with members of their healthcare team.
This will help researchers to assess how the healthcare team talk about research into different treatments.
You don’t have to agree to join the Information study if they ask you. You can still take part in the SMALL study.
Quality of life
You fill in some questionnaires:
The questions ask about:
The questionnaires take about 30 minutes to complete.
Researchers do this so that they can see whether having a VAE instead of surgery has any effect on quality of life. This is a quality of life study
Before treatment you see the doctor to have a physical examination and blood tests.
You see the doctor 6 months after treatment to see how you are.
You have a mammogram every year. And either an appointment with, or a phone call from, a member of the trial team every year to see how you are. This should take around 10 to 15 minutes. You have a follow up appointment every year for 5 years.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The side effects of VAE include bruising and bleeding. You might have a bleed in your breast. These are usually minor and don’t need further treatment.
We have information about the possible problems after a lumpectomy.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mr Stuart McIntosh
National Institute for Health Research
University of Birmingham
Birmingham Surgical Trials Consortium
Independent Cancer Patients Voice
Association of Breast Surgery
QuinteT Team, University of Bristol
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."