A trial looking at neratinib and capecitabine for breast cancer that has spread (NALA)

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 comparing neratinib and capecitabine with lapatinib and capecitabine for breast cancer that has spread (secondary breast cancer). The trial is for people whose secondary breast cancer has large amounts of the protein HER2 (HER2 positive).

More about this trial

Doctors can use trastuzumab (Herceptin) to treat HER2 positive secondary breast cancer. If this stops working they can try other treatments. Lapatinib and capecitabine is one combination of drugs that they can use. Capecitabine is a chemotherapy drug.

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

Neratinib is a type of biological therapy. It is also a cancer growth blocker.

The researchers want to compare capecitabine and lapatinib with capecitabine and neratinib to find out which is best for HER2 positive secondary breast cancer.

Who can enter

You may be able to enter this trial if

You have breast cancer that has spread to another part of your body
Your cancer has large amounts of the HER2 protein (HER2 positive)
You have already had 2 different types of treatment for your HER2 positive cancer
You have at least 1 area of cancer that can be measured on a scan
Your heart works well enough (your doctor will test for this)
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood tests results
You are willing to use reliable contraception during treatment and for a month afterwards (for women) and for 3 months afterwards (for men) if there is any chance you or your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if

Your cancer has spread to your brain and is causing symptoms. If you have been taking the same dose of steroids for the past 2 weeks and you have no symptoms you may be able to take part
You have already had capecitabine, lapatinib, neratinib or similar drugs
You have had any anthracycline chemotherapy drugs such as epirubicin or doxorubicin and the total dose is more than a certain amount (your doctor can tell you about this)
You have had major surgery in the past month
You have had any anti cancer treatment in the past 3 weeks (or 2 weeks for radiotherapy)
You have had a heart attack in the last year or have other certain heart conditions (the trial team can tell you about this)
You have an infection
You have had another cancer in the past 3 years apart from some early cancers or any other cancer that has been successfully treated
You have diarrhoea
You have hepatitis B or hepatitis C
You are known to have low levels of a protein called DPD
You are sensitive to any of the drugs used in this trial, or their ingredients
You are not able to or don’t want to swallow tablets
You have any other medical condition that could affect you taking part in this trial
You are breast feeding or pregnant

Trial design

This is an international phase 3 trial. It will recruit 600 people. It is a randomised trial. The people 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.

People in group 1 have neratinib and capecitabine
People in group 2 have lapatinib and capecitabine

NALA trial diagram

Neratinib is a tablet. You take 6 tablets once a day in the morning with food.

When you start taking neratinib you will also take tablets to stop diarrhoea. Your doctor will tell you when and how to take them. You may need to continue taking the tablets to stop diarrhoea while taking neratinib. Your doctor will talk to you about this.

Lapatinib is a tablet. You take 5 tablets once a day, an hour before or after breakfast.

Capecitabine is a tablet. Your doctor will tell you how many you need to take. You take them twice a day. You take them within 30 minutes before or after having your breakfast and evening meals. You take them for 2 weeks and then have a week of not taking them.

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

People having neratinib will have an electronic diary to fill in for the first 8 weeks of treatment. In the diary you record

When you take your neratinib
How many times you open your bowels each day
How often you take medication for diarrhoea

The trial team will ask you to fill out some questionnaires before you start treatment, every 6 weeks 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.

If you want to take part in this trial, the researchers will ask to take a new sample of your cancer (a biopsy Open a glossary item ) if a previous sample is not available to confirm your cancer’s HER2 status. You must agree to this if you want to take part in this trial.

Hospital visits

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

A physical examination
Blood tests
Tissue sample (biopsy ), if needed
Heart trace (ECG )
Heart scan (ECHO or MUGA )
CT scan or MRI scan

During treatment you see the doctor once a week for 3 weeks to see how you are. And then every 4 weeks for a physical examination and blood tests.

You have the heart trace and heart scan every 6 weeks for 3 months, then every 4 months after that.

You have a CT scan or MRI scan every 6 weeks until your cancer gets worse.

You see the doctor within 3 days after treatment finishes and then the doctor will telephone you 1 month after your last trial treatment to see how you are doing. The doctor will then telephone you every 3 months for the rest of your life or until you decided to withdraw from the trial.