A study looking at how genes may affect breast cancer chemotherapy

Please note this trial is no longer recruiting patients.

This study is looking at blood samples to see how the body handles 3 different types of chemotherapy in women and men with breast cancer. The chemotherapy drugs they are investigating are cyclophosphamide, fluorouracil (5FU) and a group of drugs called anthracyclines.

Genes are coded messages that tell cells how to behave. They control growth and development of the body. Researchers are looking into how genes affect breast cancer treatments. We know from research into other drugs that people are different in the way their bodies get rid of drugs from their bloodstream. This may be due to differences people have in their genes.

Doctors call studies looking at how the body handles drugs pharmacokinetic (PK) studies. In this study you will give blood samples before, during and after chemotherapy. The aims of this study are to

Measure the levels of chemotherapy in these samples and compare these with other people’s results in the study
Look for genes that may affect these levels, and see if there is a link

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.

Recruitment

Start 29/06/2006

End 04/05/2012

Phase

Other

Who can enter

You can enter this study if you

Have early stage breast cancer
Are due to have one of the following chemotherapy combinations: AC (doxorubicin and cyclophosphamide), FAC (fluorouracil, doxorubicin (adriamycin) and cyclophosphamide), FEC (fluorouracil with epirubicin and cyclophosphamide) or FEC-T (FEC followed by taxotere) chemotherapy
Are well enough to take part (performance status 0, 1 or 2)
Have satisfactory blood tests
Are willing to use reliable contraception if there is any chance that you could become pregnant
Are at least 18 years old

You cannot enter this study if you

Have not recovered from surgery
Are starting your chemotherapy less than 2 weeks after surgery
Have had radiotherapy or chemotherapy before
Have had any other cancer in the last 5 years except carcinoma in situ of the cervix, basal cell skin cancer or ductal breast carcinoma in situ (DCIS) that has been removed with surgery
Are pregnant or breastfeeding

Trial design

This study will recruit 70 people. Everyone will give 9 sets of blood samples during their first cycle of chemotherapy. The study team will place a small thin plastic tube (cannula) in your arm to take the samples of blood. So you will not be pricked lots of times with a needle.

Your doctor has already planned the chemotherapy you will have, and it is not part of the study. You will give blood samples before your chemotherapy, and then

At 15 minutes, 30 minutes, and 1, 2, 4, 6, 24 and 24 and a half hours after your chemotherapy
On day 12 of your first cycle of treatment

You will also keep a diary to record any side effects you have during your first cycle of treatment.

Hospital visits

You will need to be at the hospital during the first 24 hours after your first cycle of chemotherapy. This is so that the team can take the study blood samples. You do not have to stay on the ward between the sample times. You give all but two of these samples on the day of your chemotherapy. You then go home and come back the next day to give your last two samples.

You will also come to hospital on day 12 of your first cycle of treatment, to see the study team and have a blood test.