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:

Breast cancer

Status:

Closed

Phase:

Phase 2

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 menopause Open a glossary item 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 resistant Open a glossary item 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 Open a glossary item)
  • Your cancer has few, or no receptors for HER2 Open a glossary item (it is HER2 negative)
  • Your cancer continued to grow while having hormone therapy drugs called aromatase inhibitors Open a glossary item such as exemestane, anastrazole or letrozole or came back after you finished this treatment
  • You have been through the menopause (postmenopausal Open a glossary item)
  • 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 biopsy Open a glossary item. 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

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.

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

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11760

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

Rate this page:

Currently rated: 5 out of 5 based on 2 votes
Thank you!
We've recently made some changes to the site, tell us what you think