A trial looking at lapatinib trastuzumab and docetaxel for HER 2 positive breast cancer (LAPATAX)

You may be able to enter this trial if you  

• Are female and have a breast cancer (stage T2, 3 or 4) that is large and can be removed with surgery or breast cancer that is locally advanced or inflammatory breast cancer
• Have satisfactory blood test results
• Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
• Are willing to use reliable contraception for 2 weeks before starting treatment and 4 weeks after if there is any chance you could become pregnant
• Are between 18 and 70 years old

You cannot enter this trial if you

• Have cancer that has spread to another part of your body
• Have had any medication that affects the CYP3A4 enzyme in the past 10 days – you can check this with your doctor
• Have a serious heart problem
• Have a serious liver problem
• Are HIV positive
• Have had any other cancer apart from non melanoma skin cancer, carcinoma in situ of the cervix or any other cancer that has been successfully treated and there has been no sign of disease for at least 3 years
• Have any other medical condition that could affect you taking part in this trial

This is a phase 2 international trial. It will recruit 250 women from different countries around the world. This 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.  

The 3 groups are

• Docetaxel and lapatinib followed by FEC
• Docetaxel and trastuzumab followed by FEC
• Docetaxel, trastuzumab and lapatinib followed by FEC

Lapatinib is a tablet. You take it daily in the morning on an empty stomach (at least 1 hour before breakfast). You have docetaxel every 3 weeks and trastuzumab every week as a drip into a vein. You have these 3 drugs for 9 weeks. You then have FEC every 3 weeks as a drip into a vein for another 9 weeks. After 18 weeks treatment you have surgery.   

If you agree to take part in this trial the researchers will ask for a sample of tissue taken from when you had your biopsy. They will also ask for another after your treatment. If you are having surgery the sample will be taken then.

The researchers will also ask your permission to take another sample of tissue during treatment. If you don’t want to give this tissue sample you don’t have to. You can still take part in the trial.

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

• A physical examination
• Blood tests
• Heart trace (ECG)
• Heart scan (MUGA or ECHO)
• Mammogram, ultrasound or MRI scan of the breast
• Chest X-ray
• Liver ultrasound

During treatment you see the doctor every 3 weeks to have treatment, for a physical examination and blood tests. At 12 weeks you have a heart trace.

After treatment you see the doctor for

• A physical examination
• Blood tests
• Heart trace
• Mammogram, ultrasound or possibly MRI scan of the breast

You doctor will tell you how often they want to see you.

The most common side effects of lapatinib, docetaxel, trastuzumab and FEC are

• A drop in the blood cells causing an increased risk of infection, bruising or bleeding
• Feeling or being sick (nausea)
• Tiredness (fatigue)
• Hair loss
• Diarrhoea
• Constipation
• Heart damage
• Sore mouth
• Rash, dry skin
• Back, muscle or joint pain
• Difficulty sleeping
• Loss of appetite

You cannot eat grapefruit, drink grapefruit juice or take certain herbal or dietary supplements, such as St John’s Wort, grape seed, echinacea or evening primrose because they can affect the way lapatinib works in your body.  

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

We have more information on docetaxel, lapatinib, trastuzumab and FEC in our cancer drugs section.