A study looking at everolimus in women being treated with hormone therapy for breast cancer (UNIRAD)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This study is looking to see if having a drug called everolimus alongside usual hormone therapy can reduce the risk of breast cancer coming back. This trial is for women whose cancer

  • Has receptors for the hormone oestrogen (is ER positive Open a glossary item)
  • Doesn’t have receptors for the protein HER2 Open a glossary item (HER2 negative).

This trial is supported by Cancer Research UK.

More about this trial

Doctors often treat this type of breast cancer with hormone therapy. HER2 negative breast cancer is unlikely to respond to drugs such as Herceptin and researchers are looking for new treatments to help women with this type of breast cancer.

In this trial, researchers are looking at having a drug called everolimus alongside the hormone therapy you are currently having.

Everolimus is a biological therapy. It works by stopping a protein called mTOR from working properly. mTOR controls other proteins that trigger cancer cells to grow. By blocking mTOR, everolimus helps to stop the cancer growing.

Researchers think that having everolimus alongside hormone therapy will stop the cancer coming back.

The aims of this trial are to

  • Find out if the combination of everolimus and usual hormone therapy helps this group of women
  • Learn more about the side effects

Who can enter

You may be able to join this trial if you are a woman and all of the following apply

  • The doctors were able to remove all of the cancer when you had your breast cancer surgery
  • Your cancer had spread to at least 4 lymph nodes Open a glossary item or at least 1 lymph node if you had chemotherapy or hormone therapy before surgery - if your cancer had spread to 1 to 3 of your lymph nodes, you might be asked for a sample taken during surgery to be analysed before you can take part
  • Your cancer has a large number of oestrogen hormone receptors (it is ER positive Open a glossary item but doesn’t have receptors for HER2 Open a glossary item (HER2 negative)
  • You are having hormone therapy but have not had it for more than 4 years. Hormone therapy could include tamoxifen, letrozole, anastrazole or exemestane
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You are willing to use reliable contraception during the trial and for 2 months afterwards if there is any chance that you could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply

  • Your cancer has grown  into surrounding tissues, come back or spread to another part of your body
  • Your doctor thinks you might have cancer in your other breast from where it first started
  • You have certain lung conditions such as chronic obstructive pulmonary disease (COPD) or interstitial lung disease (the trial team can tell you more about this)
  • You have a long term infection
  • You have a high level of cholesterol in your blood
  • You have diabetes that isn’t well controlled with medication
  • You have hepatitis B or hepatitis C
  • You are HIV positive
  • You are sensitive to everolimus or anything that it contains
  • You have had any other cancer (including breast cancer in the other breast) in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
  • You have taken part in another clinical trial which could affect you taking part
  • You are pregnant or breastfeeding
  • You have any other medical condition or mental health problem that the doctors think could affect you taking part

Trial design

This is a phase 3 trial. The researchers need 2,000 women to join. It is a randomised trial. The women taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will you know which group you are in either. This is called a double blind study.

  • One group have usual hormone therapy and everolimus
  • The other group have usual hormone therapy and a dummy drug  (placebo Open a glossary item)

Everolimus is a tablet. You take up to 2 tablets of everolimus or the dummy drug once a day. You take your hormone therapy as usual. The trial team can tell you more about this.

You have treatment as long as it is helping you and the side effects aren’t too bad. You may have treatment for up to 2 years.

The doctors will ask you for some additional blood samples during the trial. These will be kept as part of research looking at who might benefit from having everolimus in the future. You do not have to give these samples if you don’t want to. You can still take part in the trial.

Everybody taking part will be asked to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Chest X-ray

Depending on your individual situation you may also have

The research nurse will phone you every week for the first 6 weeks to check how you are. You go to hospital once a month for a check up for the first 4 months. After that you go every 4 months. When you finish treatment, you go to hospital for a check up every 6 months for the first 2 years. After that you go once a year for 3 years. You have a mammogram once a year.

Side effects

The most common side effects of everolimus include

We have more information about everolimus.

Location

Cardiff
Dundee
Edinburgh
Glasgow
Huddersfield
London
Macclesfield
Maidstone
Nottingham
Peterborough
Sheffield
Stafford
Stoke-on-Trent
Taunton
Truro
Weston Super Mare
Wigan

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 David Cameron

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
Novartis
UNICANCER

Other information

This is Cancer Research UK trial number CRUK/13/010.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10898

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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