“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."
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.
This trial is looking at capecitabine with or without vinflunine for breast cancer that has come back after treatment with other types of chemotherapy.
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
- 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 glandsin 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
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.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- A heart trace (
- CT scan or MRI scan
- Bone scan
- 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.
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
- Feeling or being sick
- Sore mouth
- Constipation and tummy (abdominal) pain
- A reaction at the site where you have the injection
- Aching muscles or joints
- Tiredness (fatigue)
- Numbness and tingling in hands and feet (peripheral neuropathy)
Vinflunine can cause changes to the heart, but this is rare.
Other side effects of capecitabine also include
- Loss of appetite
- Red or painful skin on the hands and feet (hand foot syndrome)
How to join a clinical trial
Dr Mary O’Brien
NIHR Clinical Research Network: Cancer
Pierre Fabre Medicament