A trial using BKM120 with trastuzumab for breast cancer that has spread

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
Secondary cancers

Status:

Closed

Phase:

Phase 1/2

This trial is looking at using a new drug called BKM120 with trastuzumab for breast cancer. It was initially for people with breast cancer that had spread or was locally advanced. But later this changed so that the trial is only recruiting people whose breast cancer has spread to their brain. This trial is open to people who have HER2 positive breast cancer.

Some breast cancers have large amounts of a protein called HER2 on the surface of the cells. These cancers are ‘HER2 positive’ and can be treated with a drug called trastuzumab which targets the HER2 protein.

Cells normally divide in an organised way. But in cancer cells, proteins that help to control cell growth can change and make the cells grow more quickly.

BKM120 is a type of biological therapy called a PI3K inhibitor. PI3K is a group of proteins that help cancer cells to grow.  Blocking the PI3K proteins may help stop cancer cells from growing.

The researchers think that combining BKM120 with trastuzumab may work better than trastuzumab alone. They also think that combining BKM120 with trastuzumab and capecitabine may work for people whose breast cancer has spread to their brain.

The aims of this trial are to find out

  • How well the combination of BKM120 and trastuzumab works
  • How well the combination of BKM120, trastuzumab and capecitabine works for breast cancer that has spread to the brain
  • More about the side effects

Who can enter

You may be able to enter this trial if you

  • Have breast cancer that has spread to your brain and is HER2 positive
  • Have had radiotherapy for the cancer spread to your brain
  • Have cancer that has come back or continued to grow while having trastuzumab or within 12 months of your last treatment
  • Have had a small piece of tissue (biopsy) taken from your breast cancer
  • Have at least 1 area of cancer that can be measured on a scan
  • Have a scan that shows your cancer has grown or is new
  • Have had at least 1 and no more than 4 treatments for HER2 positive breast cancer
  • Had trastuzumab, trastuzumab DM1 (TDM1) or lapatinib as part of your last treatment
  • Have had no more than 3 chemotherapy treatments for your breast cancer
  • 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 willing to use reliable contraception while having treatment and for 6 months after if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot enter this trial if you

  • Have had a drug similar to BKM 120 before – your doctor can advise you about this
  • Are not able to have trastuzumab
  • Have already had capecitabine
  • Have DPD deficiency
  • Have cancer that has spread to the tissue around your brain and spinal cord
  • Have had radiotherapy to your whole brain in the past month or to part of your brain (radiosurgery) in the past 2 weeks
  • Have problems with your liver, kidneys or pancreas
  • Have moderate or severe tingling, numbness or pain in your hands or feet (peripheral neuropathy)
  • Have or have had a mental health problem such as depression or schizophrenia that could affect you taking part in this trial
  • Have severe symptoms of anxiety
  • Have serious heart problems that are not controlled with medication
  • Have high blood pressure that is not controlled by medication
  • Have moderate or severe diarrhoea
  • Have diabetes that is not well controlled
  • Have any condition where your body cannot properly absorb tablets
  • Have had a blood cell growth factor such as G-CSF or GM-CSF in the last 2 weeks
  • Are having steroids or any other medication that dampens down your immune system – you may join the trial if your steroids are applied to the skin (topical), inhaled for breathing disorders such as asthma, or in eye drops (you may be able to join the trial if you are having a low dose of steroids, and have been taking them for at least 2 weeks, following treatment for cancer that had spread to your brain)
  • Have had chemotherapy or any other anti cancer drugs in the last 4 weeks or 6 weeks for nitrosoureas, monoclonal antibodies (apart from trastuzumab) and mitomycin C, or if you are still having side effects from these treatments
  • Are taking any other medication that could affect you taking part in this trial
  • Have had radiotherapy to a large area of your body in the last 4 weeks
  • Have had radiotherapy to relieve symptoms to a small area of your body in the last 2 weeks
  • Have had major surgery in the last 2 weeks or are still recovering from major surgery
  • Had another cancer in the last 5 years apart from non melanoma skin cancer that has been successfully removed by surgery or carcinoma in situ of the cervix that has been removed
  • Are HIV positive
  • Are pregnant or breastfeeding

Trial design

This is a phase 1/2 trial. There are 2 parts to this trial. In the first part the researchers found out the maximum dose of BKM120 that they could give safely. This part of the trial is now closed.

The second part of the trial recruited about 60 people from different countries around the world. Everyone had BKM120 and trastuzumab. This part of the trial has completed recruitment.

The researchers have decided to extend the trial to include people whose breast cancer has spread to their brain. In this part of trial they will be looking at BKM120 combined with trastuzumab and capecitabine. It will recruit 30 people. The first people taking part will have the lowest dose of BKM120. If they don’t have any serious side effects, the next people will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

You have trastuzumab through a drip into a vein. You have it once a week.

Capecitabine is a tablet. You take it twice a day with a glass of water no more than 30 minutes after having a meal. You take it for 2 weeks followed by a week of not taking it.

BKM120 is a capsule you swallow. You take it once a day with a glass of water, 1 hour after a light breakfast, such as fruit juice, toast and jam. For 2 hours after taking BMK120 you cannot eat or drink. During these 2 hours you are able to drink water.

You can continue to have BKM120, trastuzumab and capecitabine as long as the side effects are not too bad and your doctor feels the treatment is helping you.

As part of this trial, the researchers are looking for substances in the body that they can measure to help them see how a disease is developing or a treatment is working. These are called biomarkers. To find biomarkers, the trial team will ask your permission to take some extra blood samples and also to pluck some hairs from your head or eyebrows.

The researchers will ask you to fill in a questionnaire before you start treatment, at regular times during treatment and after you finish treatment. It will ask about how you are and if the treatment has affected your moods.

The researchers will also ask your permission to take 2 extra tissue samples and an extra blood sample. You don’t have to agree to the samples if you don’t want to. You can still take part in the main trial.

Hospital visits

You will see the doctor and have some tests before starting treatment. These tests include

  • A physical examination
  • Blood tests
  • Urine test
  • CT scan or MRI scan
  • Chest X-ray – if needed
  • Heart trace – ECG
  • Heart ultrasound – ECHO

During treatment you see the doctor once a week for a physical examination and blood tests. Every 4 weeks you have a heart trace. Every 8 weeks you have a heart ultrasound and CT scan or MRI scan.

At the end of treatment you see the doctor and have the following tests

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace
  • Heart ultrasound
  • CT scan or MRI scan

After treatment you see the doctor at 1, 3 and 6 months to see how you are.

Side effects

The side effects of BKM120 may include

You cannot eat Seville oranges, grapefruit or similar fruits and their juices because they can affect the way BKM120 works in your body.

The main side effects of trastuzumab include

  • Flu like symptoms
  • Feeling or being sick
  • Headache
  • Dizziness
  • Shortness of breath
  • Changes to your blood pressure
  • Changes to the rhythm of your heart
  • Rash
  • Swelling of the face and lips
  • Tiredness

The most common side effects of capecitabine include

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

We have more information about trastuzumab and capcitabine 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

Karla Martins

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 8614

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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