A trial looking at lapatinib, Herceptin and an aromatase inhibitor for advanced breast cancer

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

Cancer type:

Breast cancer




Phase 3

This trial is looking at lapatinib, Herceptin (also called trastuzumab) and hormone therapy as the first treatment for breast cancer that has spread.

It is for post menopausal Open a glossary item women who have breast cancer that is both HER2 positive and oestrogen receptor positive Open a glossary item.

More about this trial

If you have breast cancer that is very sensitive to oestrogen, you have hormone therapy to try to stop the cancer coming back. Drugs called aromatase inhibitors are a type of hormone therapy that doctors often use.

If breast cancer cells produce large amounts of a protein called HER2, doctors can use biological therapies such as Herceptin, which target HER2.

We know from research that for breast cancer that is both oestrogen receptor and HER2 positive, having a biological therapy such as Herceptin with an aromatase inhibitor is better than having an aromatase inhibitor alone. But if the cancer comes back in another part of your body after you’ve had both these treatments, doctors aren’t sure of the best treatment to give.

The aim of this trial is to see if another type of biological therapy called lapatinib helps women with breast cancer that has come back after hormone therapy and Herceptin.

Who can enter

You may be able to enter this trial if you

  • Are post menopausal and have breast cancer that is HER2 positive and has spread to another part of your body (stage 4)
  • Have breast cancer that is very sensitive to oestrogen (oestrogen receptor positive) or to progesterone Open a glossary item (or both)
  • Had both Herceptin and hormone therapy before or after surgery to try to stop your breast cancer coming back
  • 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 enter this trial if you

  • Have breast cancer that has spread to your brain or spinal cord
  • Have breast cancer that has spread to a number of other places in your body, or your doctors can see that it is growing very quickly and they think you need to have chemotherapy
  • Have had any other cancer in the last 5 years apart from non melanoma skin cancer or a very early stage of cancer called carcinoma in situ Open a glossary item that has been successfully treated
  • Have had another experimental drug in the last 30 days (or longer if there is any chance some of the drug could still be in your body)
  • Have not recovered from side effects of earlier treatment, unless they are very mild
  • Are known to be very sensitive to any of the trial drugs, their ingredients or similar drugs
  • Have had a heart attack in the last 6 months or have certain other heart problems
  • Have liver or kidney disease
  • Have any problem with your digestive system Open a glossary item that could affect how you absorb tablets
  • Have any other medical condition that the trial doctors think could affect you taking part

Trial design

This international phase 3 trial will recruit about 525 women in a number of different countries.

It is a randomised trial. The women taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • Group A have lapatinib and Herceptin with hormone therapy
  • Group B have Herceptin with hormone therapy
  • Group C have lapatinib with hormone therapy

The hormone therapy for everyone in the trial will be an aromatase inhibitor. This is a tablet you take each day. Your doctor will choose which aromatase inhibitor you have – it may be letrozole, anastrozole or exemestane.

Women in groups A or C also have lapatinib tablets each day. Women in groups A or B have Herceptin through a drip into a vein once every 3 weeks.

As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it is helping you.

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 months during treatment and when you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

They will also ask you to give an extra blood sample. The researchers will use it to learn more about how differences in people’s genes affect how they respond to the trial drugs and the side effects they get. This is called pharmacogenetics. You don’t have to give this sample if you don’t want to. You can still take part in the main trial.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Heart ultrasound (echocardiogram Open a glossary item) or MUGA scan Open a glossary item
  • CT scan or MRI scan
  • Bone scan

The trial team will get a sample of your breast cancer that was removed during surgery. If you have cancer in your skin, they will take a photo of this area of your skin.

Everybody taking part goes to hospital every 3 weeks for the first 6 months of treatment. After that, women having Herceptin continue to go every 3 weeks, but women in group C only need to go to hospital once every 6 weeks.

You have blood tests every 3 weeks for the first 6 months of treatment and then every 6 weeks after that.

Every 12 weeks, you have a CT or MRI scan, an ECG and a heart scan. If you have cancer in your skin, the trial team will take more photos.

If your cancer has spread to your bones, you have a bone scan every 6 months.

When you finish treatment, you have another blood test. The trial team will then contact you by phone to see how you are every 3 months.

If you stop having the trial treatment for any reason other than your cancer getting worse, the researchers will ask to have a scan every 3 months until your cancer does get worse or you start another treatment.

Side effects

The most common side effects of lapatinib include

Occasionally people have an allergic reaction to lapatinib causing symptoms such as itching, wheezing or difficulty breathing.

The side effects of Herceptin (trastuzumab) include

  • A reaction when you have the drug
  • Heart problems
  • Inflammation of the lungs causing shortness of breath or cough
  • Diarrhoea
  • Back pain and tummy (abdominal) pain
  • Weakness

The side effects of aromatase inhibitors include

  • Hot flushes
  • Aching muscles and joints
  • Tiredness
  • Headaches
  • Upset stomach
  • Loss of bone density

We have more information about lapatinib, Herceptin, letrozole, anastrozole and exemestane in our cancer drugs section.

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 Stephen Johnston

Supported by

GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

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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