
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
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
You may be able to enter this trial if you
You cannot enter this trial if you
This is a phase 1/2 trial. There are 2 parts to this trial. In the first part the researchers found out the 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.
You will see the doctor and have some tests before starting treatment. These tests include
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
After treatment you see the doctor at 1, 3 and 6 months to see how you are.
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
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Karla Martins
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Novartis
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”