A trial looking at dovitinib for breast cancer that has spread

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Cancer type:

Breast cancer




Phase 2

This trial looked at a drug called dovitinib for breast cancer that had spread to another part of the body. The trial was for women who have HER2 negative breast cancer Open a glossary item. That means breast cancer that is unlikely to respond to treatment with Herceptin (trastuzumab).

If breast cancer has spread to another part of the body, it is called secondary breast cancer. Doctors can give treatments such as chemotherapy or radiotherapy, but the cancer may get worse. So researchers are looking for ways to help women in this situation.

In this trial, they looked at a drug called dovitinib (also known asTKI258). Dovitinib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

In some breast cancers, there is a large amount of a protein called fibroblast growth factor receptor 1 or FGFR1. Research in the laboratory had shown that dovitinib could stop cancer cells growing if they had large amounts of FGFR1.

The aims of this trial were to

  • See if dovitinib helps women who have secondary breast cancer with either a normal level or a large amount of FGFR1
  • Learn more about the side effects

Summary of results

The researchers found that dovitinib didn’t work for women with a normal level of the FGFR1 protein. But it could possibly help some women with too much of the protein.

81 women took part in the trial. They had all had a lot of treatment and had breast cancer that had spread to a number of different places in their bodies.

Before having treatment, the researchers tested a sample of cancer to check for the amount of the FGFR 1 protein.

When the researchers looked at the results of the tissue samples they found that,

  • 25 women had cancer with a large amount of FGFR1
  • 56 women had cancer with a normal level of FGFR1

The researchers then looked at whether or not the cancers responded to dovitinib. The cancer didn’t disappear in any of the women taking part. In 3 of the women who had a large amount of FGFR1, it looked as if the cancer responded initially, but this could not be confirmed in second assessment a few weeks later. In another 2 women with large amounts of FGFR1, the cancer didn’t get any bigger for at least 24 weeks.

The most common side effects of dovitinib were feeling or being sick, diarrhoea, and muscle weakness.

The researchers concluded that dovitinib could possibly help the group of women who had breast cancer with large amounts of the FGFR1 protein. But it wouldn’t help women who have cancer with a normal level of the protein. So doctors should know their FGFR1 status before giving dovitinib. They suggest that future trials should test dovitinib alongside a hormone therapy as this type of treatment may work best when it is combined with another drug.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

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 Nick Turner

Supported by

NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

Oracle 6057

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

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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