This trial is looking at vacuum assisted excision for breast cancers (SMALL)
Cancer type:
Status:
Phase:
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.
More about this trial
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:
- how well VAE works
- more about the side effects
- how VAE affects
quality of life
Who can enter
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:
- had a cancer found as part of the NHS breast screening programme
- have a
mammogram or an ultrasound that shows your cancer is 15mm across or less - have only 1 cancer in your breast
- have had a sample of tissue (
biopsy ) that shows the cancer is slow growing (grade 1 ) - have cancer that has many receptors for the hormones oestrogen and progesterone (ER positive and PR positive)
- have had an ultrasound,
fine needle aspiration (FNA) or core needle biopsy (CB) that shows no sign of cancer in your armpit (axilla) area - are willing to and can have surgery
- are willing to and can have
radiotherapy - are willing to and can have
hormone therapy - are at least 47 years old
Who can’t take part
You cannot join this trial if any of these apply. You:
- have cancer in both breasts
- have very small areas of calcium (microcalcification) in your breast which has shown on your mammogram that is outside the cancer
- have cancer that has receptors for
HER2 - have cancer that is in the lining of the lobules of the breast (invasive lobular carcinoma)
- have had cancer in the opposite breast unless it was successfully treated by surgery 5 years ago and there hasn’t been any sign of it coming back
- have had ductal carcinoma in situ (
DCIS ) unless it was successfully treated by surgery and there hasn’t been any sign of it coming back - are having, or had,
hormone therapy before having further treatment for breast cancer - have had another cancer in the past 5 years. This is apart from
basal cell carcinoma , in situ carcinoma of the cervix or early (superficial) bladder cancer - are considered to be at a high risk of developing breast cancer. For example several members of your family have had breast cancer. Or a member of your family has had a test showing there is a gene change (
mutation ) that might cause breast cancer - have any other medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Trial design
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:
- surgery
- vacuum assisted excision (VAE)
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 VAE in either the x-ray department or in the breast clinic. It takes about an hour. It is like having a core needle biopsy but the needle is a bit bigger.
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 6 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 might also have 1 or 2 lymph nodes in your armpit (axilla) removed. This is a biopsy. Your doctor will tell you if you are having this.
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:
- you decided to take part in the SMALL study
- healthcare professionals such as doctors and nurses presented the information about your diagnosis and treatment choices
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:
- when you join the study
- 6 months after you joined the study
- every year to 5 years
The questions ask about:
- your general health
- what you can do
- any side effects
- any costs you might have due to your treatment
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
Hospital visits
Before treatment you see the doctor to have a physical examination and blood tests.
About a month after finishing treatment your doctor will see you, or call you. This is to see how you are and if there are any complications from the treatment.
Your doctor will see you, or phone you, 6 months after you joined the trial. This is 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.
Side effects
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.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Mr Stuart McIntosh
Supported by
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
