A study looking at TKI258 to treat breast cancer that has spread

Please note this trial is no longer recruiting patients.

This study is looking at using a new drug called TKI258 to treat breast cancer that has spread to another part of the body. This study is for people who have HER2 negative breast cancer. That means breast cancer that is unlikely to respond to treatment with Herceptin (trastuzumab).

Doctors treat breast cancer that has spread with hormone therapy, chemotherapy, radiotherapy or biological therapy. Which one they choose depends on which is most suitable for you.

Researchers are always looking for new treatments to help people with breast cancer that has spread.

TKI258 is a new biological therapy called a tyrosine kinase inhibitor (TKI for short). TKIs block tyrosine kinase which is a chemical messenger (an enzyme) that sends messages to tell cells to divide and grow. Blocking the effect of tyrosine kinase may stop cancer cells growing.

We know from laboratory studies that TKI258 may shrink or slow the growth of many different types of cancers.

The aims of this study are to find out

If TKI258 can help people with HER2 negative breast cancer that has spread
How safe TKI258 is to give to women with advanced breast cancer

Recruitment

Start 23/02/2010

End 17/03/2011

Phase

Phase 2

Who can enter

You can enter this study if

You have HER2 negative breast cancer that has spread and continued to grow despite treatment
Your breast cancer has been tested for hormone receptors
Your breast cancer is hormone receptor positive and you have had at least one course of hormone treatment to treat your breast cancer after it had spread OR your breast cancer is hormone receptor negative and you have had at least one course of treatment with chemotherapy to treat your breast cancer after it had spread
You are well enough to be up and about for at least half the day and look after yourself (performance status 0, 1, 2)
You have satisfactory blood test results
You are willing to use reliable contraception during the trial, and for 4 weeks afterwards, if there is a chance that you could become pregnant
You are female and at least 18 years old

You cannot enter this study if

You have breast cancer that has spread to your brain
You have had more than 3 types of chemotherapy for your breast cancer that has spread (metastatic)
You have had ongoing treatment for your breast cancer in the last 7 days
It has been less than a week since you finished your last cycle of chemotherapy or immunotherapy
You have had nitrosoureas or mitomycin C in the last 6 weeks
You have had a biological therapy in the last 6 weeks
You have had a medication as part of another clinical trial in the last 4 weeks
Have had radiotherapy in the last 4 weeks, or radiotherapy for control of symptoms in the last 2 weeks
You have had major surgery in the last 4 weeks
You still have side effects from any treatment you have already had for your cancer
You have had any serious heart problem within the last 6 months
You have a fast heart rate that is not controlled by medication
You have a slow heart rate
You have high blood pressure that is not controlled by medication
You have problems with your digestion
You have had another cancer in the last 5 years (you may join the study if you have basal cell skin cancer or carcinoma in situ of the cervix that has been successfully treated)
You are taking a drug called warfarin to thin your blood
You are known to be HIV positive
You have any other medical condition that could affect you taking part in this study
You are pregnant or breastfeeding

Trial design

This is an international study. It will recruit about 200 people from different countries around the world.

Before taking part in the study, the researchers will ask your permission to test a sample of tissue from when you had your biopsy. This is to test for a receptor on the cancer cells called fibroblast growth factor receptor 1 (FGFR1 for short). The result of this test will determine if you can take part in the study.

Everyone taking part in the study will have TKI258. TKI258 is a capsule. You take it for 5 days and then have 2 days of no TKI258. Your doctor will tell you how many capsules you take. You should take it about the same time each day and at least 1 hour before meals or 2 hours after a light meal.

You can continue to take TKI258 for as long as your doctor feels it is helping you and the side effects are not too bad.

If you take part in this study the researchers will ask your permission to take some extra blood samples and an extra heart trace (ECG). You go to the hospital to have these done 5 days after starting TKI258. Studying these samples and the heart trace will help the researchers learn more about what happens to TKI258 in the body and how it is working.

If you don’t want to give permission for these samples or heart trace, you do not have to. You can still take part in the study.