A trial looking at vandetanib and fulvestrant and for breast cancer that has become resistant to hormone therapy (FURVA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called vandetanib alongside a type of hormone therapy drug called fulvestrant. It is for post menopausal women with breast cancer that has spread into tissue surrounding the breast (is locally advanced) or to another part of the body and has receptors for the hormone oestrogen (is ER positive). This trial is supported by Cancer Research UK.
More about this trial
Most breast cancers in women who have been through the 
need the hormone oestrogen to grow. Doctors call this oestrogen receptor positive breast cancer. Doctors treat this type of breast cancer with drugs that either reduces the amount of oestrogen the body makes or stops oestrogen getting to the cancer.
Fulvestrant is a type of hormone therapy that works by blocking oestrogen. But sometimes hormone therapies can stop working and the cancer can start to grow again. This means the cancer has become to these treatments. Researchers are looking for new treatments to help when breast cancer has become resistant to hormone therapy. In this trial they are looking at a drug called vandetanib.
Vandetanib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
Researchers think that having vandetanib alongside fulvestrant will help to control the cancer for longer.
The aims of the trial are to
- Find out if vandetanib is useful for breast cancers that have become resistant to hormone therapy
- Find out if vandetanib alongside fulvestrant together works better than fulvestrant on its own
- Learn more about the side effects
Who can enter
You may be able to join this trial if you are a woman and all of the following apply.
- You have breast cancer that has grown into tissue surrounding your breast and can’t be removed with surgery, or has spread to another part of your body
- Your doctor doesn’t think your cancer can be cured
- Your cancer has a large number of oestrogen hormone receptors (it is
ER positive ) - Your cancer has few, or no receptors for
HER2 (it is HER2 negative) - Your cancer continued to grow while having hormone therapy drugs called
aromatase inhibitors such as exemestane, anastrazole or letrozole or came back after you finished this treatment - You have been through the menopause (
postmenopausal ) - The doctor thinks more hormone therapy can help you
- The trial team can do some tests on the sample of tissue that was removed when you had your breast cancer surgery
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You are at least 18 years old
You cannot join this trial if any of these apply.
- You have cancer that has spread to your brain or spinal cord and is causing symptoms (you can take part if cancer spread to your brain was treated at least 4 weeks ago and is not causing symptoms)
- You have had fulvestrant or a similar type of drug before
- You have had more than 3 different types of hormone therapy for breast cancer (if you have locally advanced breast cancer and had one endocrine therapy before surgery, you may still be able to take part. The trial doctor can advise you about this)
- You have had more than 1 type of chemotherapy for breast cancer that is locally advanced or has spread to another part of the body
- You have had radiotherapy in the last week to help with your cancer symptoms
- You had any other anti cancer treatment in the last 3 weeks apart from hormone therapy
- You have certain heart problems (the trial team can tell you more)
- Your kidney aren’t working properly (you may still be able to take part if you have certain kidney problems. The trial team can tell you more about this)
- You have had major surgery in the last month
- You still have any moderate to severe side effects from earlier treatment apart from hair loss
- You have hepatitis B or C that is causing problems
- You are HIV positive
- You are sensitive to vandetanib or fulvestrant or anything that it contains
- You have taken part in another clinical trial in the last month
- You have any other medical condition or mental health problem that the doctors think could affect you taking part
Trial design
This is a phase 2 trial. The researchers need 160 people to join. It is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will you know which group you are in either. This is called a double blind study.
• One group have fulvestrant and vandetanib
• The other group have fulvestrant with a dummy drug (placebo)
You have fulvestrant as an injection into a muscle. You have 2 injections each time. In the first month of treatment you have the injections twice, you then have them once a month.
You take vandetanib (or the dummy tablets) everyday.
As long as you don’t have bad side effects, you can carry on having treatment for as long as your doctor thinks it is still helping you.
If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery or a . You don’t have to agree to this to take part in the trial.
Hospital visits
You will see the doctor and have some tests before you start treatment. The tests include
You see the trial doctor and have some blood tests every month or 2 to begin with and then every 3 months after that. You have a CT scan or MRI scan every 2 months for the first 6 months of treatment and then every 3 months after that.
When you finish the treatment, you go back to see the trial team within a month. The trial team will follow you up every 3 months after that to see how you are getting on.
Side effects
The most common side effects of vandetanib are
- Diarrhoea or constipation
- Skin rash and dry skin
- Feeling or being sick
- Tiredness (fatigue)
- High blood pressure
- Loss of appetite
- Headache
- Difficulty sleeping
- Feeling weak
There is a small chance that vandetanib can make your skin more sensitive to the sun. The trial team recommend that you apply sunscreen and lip balm that is sun protection factor 50 (SPF50) and avoid long periods out in the sun. You should follow this advice during the trial and for 3 months after your last dose.
We have information about the side effects of fulvestrant.
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.
Chief Investigator
Dr Mark Beresford
Dr Robert Jones
Supported by
AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Velindre NHS Trust
Other information
This is Cancer Research UK trial number CRUK/13/029
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
