A trial looking at checking inside the breast ducts for cancer cells during surgery - INTEND 1
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial wants to find out if it is useful to look at the breast ducts when a person has surgery for breast cancer.
More about this trial
Most women with breast cancer have surgery as their first treatment. If you have 
you may have an operation called a wide local excision or a lumpectomy. Your surgeon will remove the cancer along with a border of healthy tissue all around it. Pathologists look very closely at the tissue border, to make sure the surgeon has removed all the cancer cells. This lowers the risk of the cancer coming back.
If the doctors are concerned that there are cancer cells in the border of tissue they removed, you may need to have another operation.
By looking inside the ducts of the breast with a very fine telescope, it may be possible to check that all the abnormal cells have been removed during the first operation. This is called duct endoscopy. If it works, it might mean that fewer patients in the future need to have more than one operation to remove their breast cancer.
The aims of the trial are
- To find out if the telescope can get into breast ducts of different sizes and check that all abnormal tissue is removed
- To see if duct endoscopy can reduce the number of patients needing a second operation to remove their breast cancer
- To find out more about changes to cells in the breast by looking at fluid taken from the ducts
Please note you won’t get any direct benefit from taking part in this study, nor will it affect any treatment you have. It is possible that the results of this study may help to improve breast cancer surgery for women in the future.
Who can enter
You can enter this trial if you
- Have been diagnosed with breast cancer or DCIS that is going to be removed in an operation called a wide local excision or a lumpectomy
- Have breast nipples intact
- Are well enough to take part in the study
- Are female
You cannot enter this trial if you have
- Been pregnant or have breast fed in the last 6 months
- An infection in your breast
- Breast implants
- Already had surgery to the same part of the breast that is going to be operated on
- Had extensive surgery involving your milk ducts
Trial design
This is a randomised trial. It will recruit 176 women with breast cancer, diagnosed at the Royal Marsden Hospital. The women taking part will be put into two treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Half the women taking part will have duct endoscopy at the same time as their surgery. The other half will just have their surgery as planned. Before your surgery, your doctors will tell you if you have been randomised to have the duct endoscopy.
If you do have the duct endoscopy, you will have a very fine flexible telescope put into a breast duct through your nipple. The telescope allows the doctors to look at the cells lining the breast duct.
Hospital visits
Your stay in hospital will not be any longer than women not taking part in the trial and you will not have any extra hospital visits as a result of taking part.
You will have one extra blood test before your operation.
Side effects
There is a small risk that the endoscopy could cause damage to your milk duct. If this happens, it will not cause you any problem or need any further treatment.
There is also a risk that the endoscopy could cause bleeding, bruising or infection. In trials so far, nobody has developed an infection as a result of duct endoscopy. It is unlikely, but if this was to happen, it would be treated with antibiotics.
The main side effects of surgery are the risk of infection and bleeding. There is more information about surgery for breast cancer on CancerHelp UK.
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 Gerald Gui
Dr Ana Agusti
Supported by
Breakthrough Breast Cancer
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
