A trial looking at afatinib and radiotherapy for lung or breast cancer that has spread to the brain (CamBMT1)

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

Cancer type:

Breast cancer

Cancer spread to the brain

Lung cancer

Secondary cancers

Status:

Closed

This trial is looking at whether a single dose of radiotherapy improves the way afatanib works on cancer that has spread to the brain. It is for people with breast cancer or lung cancer that has spread to the brain and who can have surgery to remove the cancer. This trial is supported by Cancer Research UK.

More about this trial

Breast and lung cancer can often spread to the brain. Cancer that has spread to the brain is also known as brain metastases or secondary brain cancer. Doctors can treat secondary brain cancer with either radiotherapy or surgery, but it can be difficult to treat with cancer drugs. This is because the brain is protected by a blood brain barrier. This is a natural filter within the body. It only allows certain substances through from the blood to the brain tissues.

In this trial, doctors want to see if they can improve the outlook for people with secondary brain cancer by giving one low dose of radiotherapy and a cancer drug called afatinib. They want to see if the radiotherapy will disrupt the blood brain barrier allowing more afatinib to get through. The radiotherapy will be either 3-D conformal radiotherapy (3DCRT) or intensity-modulated radiotherapy (IMRT).

Everybody taking part in the trial will also have surgery to remove secondary brain cancer. You would have surgery whether you were taking part in the trial or not.

The aims of the trial are to find

Whether radiotherapy allows more afatinib to reach the cancer spread to your brain.
The best dose of afatinib to have alongside radiotherapy
The best dose of radiotherapy to give

Who can enter

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

Have cancer spread to the brain and the cancer started in either your breast or lung (primary breast cancer or primary lung cancer)
Can have surgery to remove the cancer that has spread to your brain
Are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old

Women taking part must be willing to use an effective contraceptive for 1 week before starting the trial, during the trial and for 28 days after the final dose of afatinib. Men must be willing to use an effective contraceptive during the trial and for 28 days after the final dose of afatinib.

If you are taking steroids you should have the same dose for at least 3 days before the surgery to remove the cancer spread to your brain.

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

Have had chemotherapy, immunotherapy, or any experimental drug in the 2 weeks before starting the trial
Have had radiotherapy in the 2 weeks before starting the trial
Have started hormone therapy within 2 weeks of starting the trial. If you are already taking hormone therapy you can continue with it as long as you have been taking it continously for at least 2 weeks before starting the trial
Have side effects from any earlier cancer treatments that are causing you problems
Have a type of lung condition known as interstitial lung disease (your doctor can advise you about this)
Have certain heart problems (the trial doctor can advise you about this)
Have a serious eye infection
Have a skin disease such as psoriasis, eczema or a rash that your doctor thinks is significant
Have problems with your digestive system that may affect how you absorb afatinib
Have a peptic ulcer which requires treatment
Have any other medical problem that the trial team think could affect your taking part
Have hepatitis B, hepatitis C or are HIV positive
Use drugs or alcohol in a way that concerns the trial team
Are known to be allergic to afatinib
Take certain drugs that could affect how well afatinib works, these include some antibiotics, some drugs used to treat heart conditions and high blood pressure and the herbal medicine St John’s wort (your doctor can advise you about this)
Are pregnant or breastfeeding

Trial design

This trial is in 2 parts and is called a phase 1/ 2 trial. Doctors need up to 36 people to take part in phase 1 and around 60 people to take part in phase 2. Doctors need the results from phase 1 before they move on to phase 2.

In phase 1 the doctors want to find the best dose of afatinib to give with radiotherapy. People taking part will be put into 1 of 2 groups. The group you are in will depend on when you join the trial, neither you nor your doctor will be able to decide which group you will be in. The doctors are aiming to have up to 18 people in each group. The first few people will have a low dose of afatinib. If they don’t have bad side effects the next few people will have a higher dose. The doctors aim to look at 3 different doses of afatinib. They are also looking at 2 different doses of radiotherapy.

People in group 1 will have afatinib tablets over 11 days. On day 10 they will have a single dose of radiotherapy.
People in group 2 will have afatinib tablets over 11 days. On day 10 they will have a single dose of radiotherapy. This dose of radiotherapy will be higher than the dose given to the people in group 1.

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Phase 1 has now closed. Everyone taking part will now be in phase 2.

In phase 2, the doctors want to compare the best dose of afatinib (decided in phase 1) in combination with 2 different doses of radiotherapy and no radiotherapy at all. Phase 2 is randomised. The people taking part in phase 2 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 afatinib over 11 days
People in group 2 have afatinib over 11 days and 1 dose of radiotherapy on day 10
People in group 3 have afatinib over 11 days and a higher dose of radiotherapy on day 10

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Everybody joining both parts of the trial will go on to have surgery on day 12. You may also be offered more radiotherapy after your surgery.

Afatinib is a tablet that you take at home. The trial team will give you a diary card to record the date and time you take your tablets. Either your nurse or a doctor from the trial team will call you between 3 and 6 days after you start taking the tablets to see how you are.

The trial team may ask you to take part in an MRI sub study. To take part you must be able to have MRI scans. This sub study is looking at how well afatinib works. If you take part in the MRI sub study, you will have 2 separate scans before starting afatinib. Then you will have a scan before you have your radiotherapy and another scan before your surgery.

Hospital visits

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

Physical examination
Blood tests
Urine test
Heart trace (ECG)
MRI scan (if taking part in the MRI sub study)

If you are in a group having radiotherapy you will have a planning visit. This will include a CT scan, MRI scan and fitting for a mask. The mask keeps your head completely still while you are being treated. Usually the MRI scan can also be used to plan your operation.

You will have 1 visit to the hospital for your radiotherapy. This will be on day 10 of the trial. On day 12 you will have your surgery. About 10 days after your operation you will see your doctors and have a physical examination, blood and urine tests and an ECG. About 4 weeks after you operation you will have a final visit to see your doctors and have the same tests.

Side effects

Combining afatinib and radiotherapy is a new treatment and there may be some side effects that we don’t know about yet, but your trial team will be looking out for this. As well as seeing them regularly you will have a phone number to contact them if you are worried about anything.

The following are very common side effects of afatinib but as you take the tablets for 11 days, the doctors hope the side effects will be less than when the drug is taken for a number of months.

We have more information about afatinib.

Radiotherapy can cause side effects but the dose in this trial is small and the doctors do not expect you to have any serious side effects. You may

Feel sick
Feel tired

Recruitment start:

26/02/2015

Recruitment end:

12/08/2020

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.

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Chief Investigator

Dr Richard Baird

Supported by

Cancer Research UK
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Experimental Cancer Medicine Centre
The Brain Tumour Charity
Boehringer-Ingelheim
NCRI Radiotherapy Trials QA Group (RTTQA)