“I had treatment last year and I want to give something back.”
A trial looking at gemcitabine with either vinflunine or paclitaxel, for breast cancer that has come back after treatment or spread to another part of the body (VICTORIA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing 2 different combinations of chemotherapy drugs for breast cancer that has come back in the breast or lymph nodes under the arm and cannot be removed with surgery, or has spread to another part of the body.
Doctors use surgery, radiotherapy, chemotherapy, hormone therapy and biological therapy to treat breast cancer. But sometimes it comes back after treatment. This is called recurrent breast cancer. If the cancer comes back in the breast or in the lymph nodes under the arm, doctors describe it as being locally recurrent. If the cancer comes back somewhere else in the body, it is called metastatic breast cancer.
If you have locally recurrent or metastatic breast cancer, you may have more chemotherapy. A combination of the drugs paclitaxel and gemcitabine is already in use. In this trial, researchers are comparing this with another combination of gemcitabine and a drug called vinflunine.
The aims of the trial are to
- See if vinflunine and gemcitabine work as well as paclitaxel and gemcitabine for locally recurrent or metastatic breast cancer
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have breast cancer that has come back in the breast or under the arm, or has spread to another part of the body
- Had chemotherapy when your breast cancer was first treated
- Have breast cancer that is HER2 negative, or your HER2 status is not known
- Have satisfactory blood test results
- Are well enough to take part
- Are between 18 and 75 years old
- Are willing to use reliable contraception for 2 months before the trial, during the trial, and for 3 months after, if there is any chance you could become pregnant
You cannot enter this trial if you
- Have breast cancer that your doctors think they can cure with surgery or radiotherapy
- Have inflammatory breast cancer that has not spread anywhere else in your body
- Have breast cancer that has spread to your brain
- Have had chemotherapy in the last year
- Have had radiotherapy that involved more than a quarter of your
- Have had radiotherapy in the last 4 weeks
- Have had a bone marrow or stem cell transplant
- Have had any other cancer treatment (apart from hormone therapy) in the last month
- Are going to carry on having hormone therapy
- Have already had treatment with gemcitabine or one of a group of drugs called vinca alkaloids
- Are known to react to any of the drugs used in the trial
- Already have nerve damage (peripheral neuropathy) unless it is very mild
- Have had a heart attack in the last 6 months
- Have any other serious medical condition that cannot be controlled with medicine
- Have had another cancer, apart from breast cancer in both breasts, carcinoma in situ of the cervix, non melanoma skin cancer that has been successfully treated or any other cancer that has been treated and been in
remissionfor at least 5 years
- Are pregnant or breastfeeding
This is an international trial. It will recruit about 1,000 people in different countries around the world. It is a randomised trial. The people taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part will have treatment in 3 week (21 day) cycles of treatment. You have treatment through a drip into a vein on the 1st and 8th day of each 3 week cycle.
If you are in group A, you have vinflunine and gemcitabine on day 1. This will take just under an hour. And on day 8, you have gemcitabine alone, which takes about half an hour.
If you are in group B, you have gemcitabine and paclitaxel on day 1. This will take about 3 and a half hours. And on day 8, you have gemcitabine alone which takes about half an hour.
Everybody will have at least 2 cycles of treatment unless they have bad side effects. Most people taking part will have about 6 cycles of treatment. But you may carry on having treatment for longer if it is helping.
You will be asked to fill in a questionnaire
- At the beginning of the trial
- Just before the 2nd cycle of treatment
- Just before every alternate cycle of treatment you have after that
- Shortly after you finish 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
You will go to hospital to have chemotherapy twice in each 3 week cycle of treatment. You will have regular blood tests and a scan every 6 weeks.
When you finish your treatment, you will go back to see the doctors within a month. You will have a physical examination, blood tests and a scan.
The chemotherapy drugs in this trial can cause a drop in the number of blood cells causing an increased risk of infection, tiredness, breathlessness, bruising and bleeding problems.
Other side effects of vinflunine include
Other side effects of gemcitabine include
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.
Dr D Talbot
Experimental Cancer Medicine Centre (ECMC)
Pierre Fabre Medicament