A trial of LEE011 alongside letrozole for advanced breast cancer (MONALEESA 2)

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 trial is looking at a new drug called LEE011 alongside letrozole for advanced breast cancer. It is for women whose breast cancer has come back in the same place or has spread to another part of the body (advanced breast cancer). The cancer cells must have receptors for the female sex hormones oestrogen or progesterone.

Doctors treat breast cancers that have hormone receptors with hormone therapy. One type of hormone therapy is letrozole. They use letrozole to treat breast cancer in women who have had their menopause (are post menopausal).

LEE011 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers want to find out if LEE011 alongside letrozole can help women with advanced breast cancer. In this trial some women will have LEE011 alongside letrozole and some will have a dummy drug (placebo Open a glossary item) alongside letrozole.

The aims of this trial are to find out

  • How well the combination of LEE011 and letrozole works for women with advanced breast cancer
  • What the side effects are
  • How this combination of drugs affects the quality of life of these women

Who can enter

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

  • Are a woman who has been through the menopause (you are post menopausal Open a glossary item)
  • Have breast cancer that has spread to another part of your body, or your cancer has come back in the same area, and you can’t have treatment with the aim of curing it
  • Have cancer that has receptors for the female sex hormones oestrogen or progesterone (your doctor can tell you this)
  • Have an area of cancer that can be measured on a scan or you have an area of cancer in your bones
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are at least 18 years old

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

  • Have cancer that has spread to your brain or spine
  • Have breast cancer that has a lot of the HER2 protein, that is to say it is HER2 positive (your doctor can tell you this)
  • Have inflammatory breast cancer
  • Have already had treatment for your advanced breast cancer
  • Are currently having treatment for your cancer
  • Have had radiotherapy Open a glossary item in the past 4 weeks
  • Have had more than 2 weeks of steroids or still have side effects from taking them apart from creams, inhalers or eye drops
  • Have already had LEE011 or drugs that work in a similar way (your doctor can tell you this)
  • Still have side effects from any previous treatment apart from hair loss
  • Have had major surgery in the past 2 weeks or have not recovered from any complications or side effects
  • Have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer or cervical cancer that has been successfully treated with surgery
  • Have a problem with your digestive system Open a glossary item that could affect the way the study drugs are absorbed
  • Take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
  • Have certain heart problems (the trial team can advise you about this)
  • Are HIV positive
  • Have any other medical condition or mental health problem that your doctor thinks may affect you taking part in the trial

Trial design

This is an international phase 3 trial. The researchers need 500 women from around the world to join.

It is a randomised trial. The people taking part are put into 1 of 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 know which group you are in. This is called a double blind trial.

  • 250 women will have LEE011 alongside letrozole
  • 250 women will have a dummy drug (placebo Open a glossary item) alongside letrozole

12331 Trial Diagram

Letrozole is a tablet you take once a day. LEE011 and the dummy drug are tablets you take every day for 3 weeks and then have a week of not taking them. Your doctor will tell you how many you need to take.

You continue having treatment as long as it is helping you and the side effects aren’t too bad.

The trial team will ask you to fill out 3 questionnaires before you start treatment, every 8 weeks for 1½ years and then every 3 months during treatment and after you finish treatment. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

The researchers will ask for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • 3 heart traces (ECG Open a glossary item)
  • Heart scan (MUGA Open a glossary item or ECHO Open a glossary item)
  • CT scan or MRI scan
  • Bone scan if needed

You see the doctor twice in the first month of treatment and then every month afterwards for

  • A physical examination
  • Blood tests
  • 3 heart traces

You have a CT scan or MRI scan every 2 months for 1½ years and then every 3 months until your cancer starts to grow again.

At the end of treatment you see the doctor for the same tests you had at the start. You then see the doctor every 3 months.

Side effects

LEE011 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

We have information about the side effects of letrozole.

Your doctor will talk to you about all the possible side effects before you agree to take part in the trial.

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

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12331

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

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

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