A trial comparing surgery with active monitoring for low risk DCIS (LORIS)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This trial is comparing surgery with monitoring by having yearly mammograms for low risk ductal carcinoma in situ (DCIS).

More about this trial

DCIS means that there are abnormal cells in the milk ducts in your breast but not in any other breast tissue.

Doctors can classify DCIS as high, intermediate or low grade. Because high grade DCIS is more likely to become breast cancer, it is treated as if it is an invasive cancer. But many doctors are not sure that low or intermediate grade DCIS would ever become invasive cancer.

Most women have surgery to remove DCIS. This may be surgery to remove the breast (a mastectomy). Or it may be surgery to remove just the area of the breast containing the DCIS (a wide local excision).

In this trial, some women will have surgery. Some won’t have surgery, but will have a mammogram once a year for 10 years. The researchers call this active monitoring.

The aim of the trial is to learn whether women with low risk DCIS can safely avoid having surgery.

Who can enter

You may be able to join this trial if all of the following apply. You

  • Are a woman and are at least 46 years old
  • Have been diagnosed with DCIS in the last 3 months
  • Have DCIS that is not classed as high grade
  • Are fit enough to have surgery

You cannot join this trial if any of these apply. You

  • Have already had breast cancer or DCIS in the same breast that you have DCIS in now (you can take part if you’ve had DCIS in the other breast and this was removed with surgery)
  • Had a lump in your breast that could be felt or seen on a mammogram or ultrasound scan before you had a biopsy that confirmed you had DCIS
  • Have any other serious medical condition that could affect your taking part (the trial team can advise you about this)
  • Have recently started having a blood stained discharge from your nipple (on the same side as your DCIS), unless this has been diagnosed as a condition called ductal ectasia
  • Are at high risk of getting breast cancer because of your family history or because you have had radiotherapy to your chest in the past

Trial design

This is a phase 3 trial. The researchers need more than 900 women to take part. It is a randomised trial. The women taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor or nurse will be able to decide which group you are in.

Women in one group have surgery to remove DCIS. Women in the other group have active monitoring.

12233 Trial Diagram

If you are in the group having surgery, you may have a mastectomy. Or you may have surgery to remove just the area of the breast containing the DCIS (a wide local excision). You may also have radiotherapy or hormone therapy. After your treatment, you have a mammogram once a year for 10 years. You will be told the result of each mammogram by letter.

If you are in the group having active monitoring, you don’t have surgery. You have a mammogram once a year for 10 years. You don’t need to see a doctor or have a breast examination unless any changes are picked up on your mammogram. You will be told the result of each mammogram by letter.

Whichever group you’re in, if you have any concerns and want to see a doctor, you can contact your hospital research team.

The trial team will ask you to fill out some questionnaires asking about how you are feeling and your quality of life

  • When you join the trial
  • 3 times in the first year
  • Once in years 2, 3, 4 and 5

The trial team will also send you a short questionnaire that helps them compare any costs to women in each group.

If you agree, a researcher may contact you by phone after you are put into your treatment group. This is to find out what you think of the trial.

Hospital visits

Everybody taking part in the trial will have a mammogram once a year for 10 years.

If you are in the group having surgery, you may also have follow up hospital appointments once a year for 5 years if that is the standard care at the hospital where you have your treatment. After 5 years, a member of the trial team at your hospital will phone you each year to see how you are. This will take about 10 minutes each time.

If you are in the group having active monitoring, a member of the trial team will phone you once a year for 10 years.

After 10 years, if you are still in the age range for breast screening, you will rejoin the NHS Breast Screening Programme and have a mammogram every 3 years.

Side effects

There is a small chance that women in either group will develop higher grade DCIS or invasive breast cancer that needs treatment.

Everybody in the trial has a mammogram once a year for 10 years. This is longer than standard treatment Open a glossary item which is currently 5 years. Mammograms use X-rays to give an image of the breast, so you will be exposed to some extra radiation. But the risk of this causing another breast cancer is very small compared to the natural risk of breast cancer.

There are risks associated with having surgery, such as bleeding and wound infections. There are also side effects of radiotherapy and hormone therapy. Your doctor or specialist nurse will give you more information this.

Location

Belfast
Birmingham
Bolton
Brighton
Bristol
Cambridge
Carlisle
Chester
Chesterfield
Cottingham
Derby
Dundee
Edinburgh
Exeter
Glasgow
High Wycombe
Kilmarnock
Leeds
Leicester
Liverpool
Llanelli
London
Luton
Macclesfield
Manchester
Newcastle upon Tyne
Norfolk
Nottingham
Oxford
Peterborough
Portsmouth
Sheffield
Southampton
Southend on Sea
Stoke-on-Trent
Sutton
Truro
Wirral
York

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Adele Francis

Supported by

Cancer Research UK Clinical Trials Unit
Birmingham
Experimental Cancer Medicine Centre (ECMC)
NIHR Health Technology Assessment (HTA) programme
University of Birmingham

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12233

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“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."

Last reviewed:

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