
“I had treatment last year and I want to give something back.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called cobimetinib and a chemotherapy drug called paclitaxel for triple negative breast cancer. This means the breast cancer doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2. The trial is for people whose cancer has grown into surrounding tissue (is locally advanced) or has spread to another part of their body.
Doctors sometimes use a chemotherapy drug called paclitaxel for triple negative breast cancer. This works well but doctors are looking at ways to improve treatment. In this trial, they are looking at a drug called cobimetinib.
Cobimetinib is a type of biological therapy. It works by targeting a protein called MEK and stop signals that cancers use to divide and grow. The researchers think that combining cobimetinib with paclitaxel may improve treatment.
This trial will compare cobimetinib and paclitaxel with paclitaxel alone. The aims of the trial are to
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if all of the following apply
You cannot join this trial if any of these apply. You
This is a phase 2 trial. The researchers need 112 people to join.
This study is in 2 parts. In part 1, the researchers are looking at the side effects of having cobimetinib and paclitaxel. In the 2nd part, the researchers want to compare cobimetinib and paclitaxel with paclitaxel alone.
In part 1, 12 patients will have cobimetinib alongside paclitaxel. When the researchers have know more about the side effects then part 2 can begin.
Part 2 is randomised. 100 people will join this part of the trial. The people taking part are put into 2 different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
You have paclitaxel through a drip into a vein. You have it once a week for 3 weeks out of every 4. This takes about an hour each time. Each 4 week period is called a cycle of treatment.
Cobimetinib is a tablet. You have either cobimetinib or dummy tablets (which look exactly the same). You take 2 or 3 tablets once a day for 3 weeks of each treatment cycle starting on the 3rd day of the treatment cycle.
You have treatment for as long as it is helping you and the side effects aren’t too bad.
During the trial, the researchers take a number of blood samples. They will also ask for a sample of your cancer that was removed when you had surgery or a biopsy in the past and for another biopsy if your cancer gets worse. The researchers will use these samples to look for substances called biomarkers that may help them understand more about how cobimetinib and paclitaxel work together and how the drugs affect your tumour.
The trial team will ask everybody taking part in the trial to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how treatment affects you physically and emotionally.
You see the trial doctor to have some tests before taking part in the trial. These include
You go to hospital once a week for 3 weeks to have the paclitaxel. You take the cobimetinib or dummy drug at home. You see the trial doctor twice a month for a physical examination. You have regular blood tests and eye tests during treatment.
You have a CT or MRI scan every 2 months until your cancer gets worse. When you finish treatment the trial team will contact you every 3 months. They will either phone you or check your medical records to see how you are.
As cobimetinib is a new drug, there may be side effects that we don’t know about yet. The most common side effects so far include
There is a very small risk of developing blurred vision while having cobimetinib. This is caused by a build up of fluid within the layers around the eye lens (the retina). This side effect is usually temporary and goes away when you stop taking the drug. You will have regular eye examinations during the trial to check for this.
We have information about the side effects of paclitaxel.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Tamas Hickish
Roche
Freephone 0808 800 4040
“I had treatment last year and I want to give something back.”