Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial looking at cabazitaxel for HER 2 negative breast cancer that has spread to the brain (CiPHER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called cabazitaxel for people with breast cancer that has spread to their brain.
More about this trial
Breast cancer cells often have receptors for a protein called
People with HER2 negative breast cancer do not benefit from treatment with certain types of biological therapy such as Herceptin (Trastuzumab). This means they have fewer treatment choices and researchers are looking for new ways to help them. In this trial they are looking at a chemotherapy drug called cabazitaxel (also known as Jevtana).
Doctors use different treatments when breast cancer has spread to the brain including steroids, radiotherapy, and biological therapy. It can be difficult to treat breast cancer that has spread to the brain with chemotherapy, 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. We know from research that cabazitaxel can cross the blood brain barrier.
The aim of this trial doctors is to see if cabazitaxel helps people with HER2 negative breast cancer that has spread to the brain.
Who can enter
You may be able to enter this trial if
- You have
HER2negative breast cancer that has spread to your brain
- The cancer in your brain cannot be removed with surgery or treated with stereotactic radiotherapy
- The cancer in your brain can be measured with a CT scan or MRI scan
- You are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
- You have satisfactory blood test results
- You are willing to use reliable contraception while taking part in the trial, and for 12 months afterwards, if there is a chance that you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have had any chemotherapy after the cancer in your brain was found
- Have had surgery, chemotherapy or any other anti cancer treatment in the last 3 weeks
- Are having hormone therapy (unless you stop this when you take part in the trial)
- Have had increasing doses of steroids to control symptoms from the cancer in your brain in the last 2 weeks (if you are on a stable dose of steroids you may still be allowed to take part in the trial)
- Have nerve damage affecting your hands or feet (peripheral neuropathy) unless it is only mild
- Have a very sore mouth (
- Have an infection that is being treated with antibiotics or anti fungal medication
- Have had any other type of cancer in the last 10 years apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated
- Have taken an experimental drug as part of another trial in the last month
- Have any medical condition such as diabetes that is not controlled with medication and could affect you taking part (your doctor can advise you about this)
- Have had any medication that affects a protein in your body called the CYP3A4 enzyme in the last 7 days (your doctor can advise you about this).
- Are known to be very sensitive to any of the drugs in the trial
- Are planning on having the yellow fever vaccine
- Are pregnant or breastfeeding
This is a phase 2 trial. The researchers need 108 people to take part. 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.
For every 3 people joining the trial, 2 will have cabazitaxel and 1 will not.
If you have had radiotherapy to the cancer in your brain, you have either
- A treatment that your doctors think will help you
If you have not had radiotherapy to the cancer in your brain, you either have
- Cabazitaxel (if your cancer gets worse while you’re having this drug you will go on to have radiotherapy)
If you have cabazitaxel, you have treatment once every 3 weeks. This is called a cycle of treatment. You have up to 6 cycles in total. This will take about 18 weeks. Your treatment may stop sooner if
- The treatment isn’t working
- The side effects become too much
- You decide you wish to stop treatment
After you have had 6 cycles of treatment, your doctor may suggest you continue with treatment if they think it has helped you.
If you are in the group having radiotherapy, your doctor will explain what will happen to you. You might have a course of external radiotherapy over 1 to 2 weeks.
The trial team will ask everybody taking part in the trial to complete some questionnaires before treatment starts and then at regular periods throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.
You see the doctor to have some tests before taking part in the trial. These include
- A physical examination
- A heart trace (
- CT scan or MRI scan of your head
- CT scan of your chest, tummy (abdomen) and the area between your hip bones (pelvis)
- Bone scan
- Blood tests
If you have cabazitaxel, you visit the hospital every 3 weeks to have treatment. To help reduce the risk of infection you have an injection of a drug called Neulasta 24 hours after you have cabazitaxel. You don’t need to go into hospital for this. You or a friend or relative can be taught to give the injection. Or a nurse can visit you at home to give you this drug.
Your doctor will explain how often you need to go to hospital if you have radiotherapy.
Everyone taking part in the trial will have regular blood tests during treatment and an MRI or CT scan of their head every 6 weeks. You have a CT scan of your chest, tummy (abdomen) and the area between your hip bones (pelvis) 12 weeks after starting treatment and then every 6 weeks until you finish treatment.
If you have more than 6 cycles of treatment, you have a CT scan or MRI scan of your head and a CT scan of your chest, tummy (abdomen) and the area between your hip bones (pelvis) every 8 weeks.
You will see the trial team about 4 weeks after you finish your treatment. You will then see them every 2 months. If you are not well enough to go the hospital the trial team may call you at home or speak with your GP to find out how you are.
The most common side effects of cabazitaxel include
- High temperature (fever)
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Loss of appetite
- Taste changes
- Shortness of breath
- Feeling or being sick
- Tummy (abdominal) pain
- Hair loss
- Pain in your joints or back
- Blood in your urine
- Tiredness (fatigue)
How to join a clinical trial
Dr Zafar Malik
Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool Cancer Trials Unit