A study looking at changes inside the breast ducts of women who have nipple discharge (INTEND II)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This study wants to find out if it is useful to look inside the breast ducts of women who have nipple discharge.

If you have a discharge from your nipple, your GP may refer you to a specialist breast clinic as it can be a sign of breast cancer. At the breast clinic, you will have tests such as a mammogram and an ultrasound scan. Sometimes these tests are clear. Even though most women who have nipple discharge do not have cancer, there is a chance that there could be a small cancer that is not showing up on the scans. So doctors may want to remove some breast tissue from behind the nipple to check.

In future, it may be possible to use a very fine telescope to see inside the ducts and check for abnormal areas. This is called duct endoscopy. If it works, it might mean that doctors can remove less breast tissue to check for cancer. But the researchers need to find out if the telescope can get into breast ducts of different sizes.

The aims of this trial are

To find out if duct endoscopy can show up abnormal areas inside the breast ducts
To see if using duct endoscopy means doctors can remove less breast tissue when checking for breast cancer
To find out more about changes to cells in the breast by looking at fluid taken from the ducts

Please note that 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 how breast cancer is diagnosed in the future.

Who can enter

You can enter this trial if you

Have nipple discharge
Are having an operation to investigate nipple discharge by removing some breast tissue
Have had a mammogram and ultrasound scan
Have intact nipples (no nipple piercing)
Are well enough to take part in this study
Are female

You cannot enter this trial if you have

Already had surgery or a biopsy to remove tissue from the same part of the breast that is going to be operated on
Had breast cancer, Paget’s disease or DCIS in the past
Had chemotherapy in the last 6 months
An infection in your breast
Had surgery to your nipple or breast ducts in the past
Breast implants
Been pregnant or have breast fed in the last 6 months

Trial design

This is a randomised trial. It will recruit about 70 women at the Royal Marsden Hospital who are having an operation to find the cause of nipple discharge.

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 are in the group having duct endoscopy.

If you do have the duct endoscopy, the doctors will put a very fine, flexible telescope through your nipple and into your breast ducts. The telescope allows the doctors to look at the cells lining the breast ducts before any tissue is removed.

Hospital visits

Your stay in hospital will not be any longer than for women not taking part in the trial and you will not have any extra hospital visits as a result of taking part.

Side effects

There is a small risk that the endoscopy could cause damage to your breast 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.