A trial of the chemotherapy drugs capecitabine and vinflunine for advanced breast cancer

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 3

This trial is looking at capecitabine with or without vinflunine for breast cancer that has come back after treatment with other types of chemotherapy.

Doctors usually treat breast cancer with surgery, and one or more of chemotherapy, radiotherapy, hormone therapy or biological therapy.

But sometimes the cancer comes back (recurs) or spreads (metastasises) to another part of the body. This is advanced, metastatic or secondary breast cancer.

If you have advanced breast cancer, you may have more chemotherapy. One of the drugs doctors use is called capecitabine. In this trial, researchers are looking at adding another chemotherapy drug called vinflunine.

The aims of the trial are to see

If a combination of capecitabine and vinflunine works better than capecitabine alone for women with advanced breast cancer
How each treatment affects quality of life

Who can enter

You can enter this trial if you

Are a woman with breast cancer that has come back, either in the breast or in another part of your body, and your doctors don’t think it can be cured with surgery or radiotherapy
Have already had a chemotherapy drug called a taxane (such as Taxol), and your cancer came back during treatment, or shortly afterwards
Have already had a chemotherapy drug called an anthracycline
Have recovered from any surgery you have had
Have satisfactory blood test results
Are well enough to take part in the trial (Karnosky score of at least 70)
Have been using a reliable method of contraception, if applicable, for at least 2 months before joining the trial and are willing to carry on doing so during the trial and for 3 months after the treatment ends
Are at least 21 years old

You cannot enter this trial if you

Have breast cancer that has spread to your brain or spinal cord (central nervous system)
Have cancer that has spread to the lymph glands in your lungs (pulmonary lymphangitis) or have a build up of fluid in the lungs (pleural effusion ), and either of these are causing problems that need treating
Have already had more than 3 types of chemotherapy (if you have had a lot of chemotherapy, you will need to talk to the trial doctors about whether or not you can take part)
Have already had capecitabine or vinflunine, or similar drugs called vinca alkaloids (such as vinorelbine)
Have had hormone therapy for breast cancer in the last 2 weeks, or biological therapy in the last 3 weeks
Have had a bone marrow or stem cell transplant
Have had an experimental drug as part of another clinical trial in the last month
Have had radiotherapy in the last 4 weeks, or earlier radiotherapy to more than a third of your bone marrow (your doctor can advise you about this)
Have had another cancer, apart from cancer in the other breast, carcinoma in situ of the cervix, or non melanoma skin cancer that have been successfully treated, or any other cancer that was treated at least 5 years ago and there have been no signs of it coming back since
Already have damage to the nerves in your hands or feet (peripheral neuropathy) unless it is very mild
Have had a heart attack in the last 6 months or have any other serious medical condition including (but not limited to) heart failure, high blood pressure that cannot be controlled with medication or angina
Cannot swallow or absorb tablets for any reason
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial, which will recruit about 750 women in different countries. It is a randomised trial. The women taking part will be put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

You have chemotherapy in 3 week cycles of treatment. The women in group A have vinflunine through a drip into a vein on the first day of each treatment cycle. And they have capecitabine tablets twice a day, every day for 2 weeks. This is followed by a week without any treatment, before starting the next cycle.

Women in group B have capecitabine tablets in the same way, but they do not have vinflunine.

As long as you don’t have bad side effects, you will have 2 cycles of treatment and then a scan to see if treatment is helping you. If it is, you can carry on having treatment for longer.

The trial team will give you a diary to keep at home and fill in each day. In it, you record

The number of capecitabine tablets you take
Any other medication you take and what you take it for

You will also be asked to fill out a questionnaire before you start treatment, after every 2 cycles of chemotherapy and then at the end of your treatment. The questionnaire will ask you about any side effects you have had and about how you have been feeling. This is called a quality of life study.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
A heart trace (ECG )
CT scan or MRI scan
Bone scan
X-rays
Pregnancy test (if there is any chance you could be pregnant)

You go to hospital every 3 weeks during treatment. And you have a blood test before each cycle of treatment.

If you don’t have any bad side effects, you can carry on having treatment for as long as it helps you. You have scans every 6 weeks during treatment and at the end of treatment.

After you finish treatment, you will see the doctors every 6 weeks until your cancer starts to grow again, then every 6 months after that.

Side effects

A common side effect of chemotherapy is a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness.

Other side effects of vinflunine include