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.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

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 bone marrow
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 remission for at least 5 years
Are pregnant or breastfeeding

Trial design

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.

Hospital visits

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

Physical examination
Heart trace (ECG )
CT scan or MRI scan
X-rays
Bone scan

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.

Side effects

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

Sickness
Sore mouth
Constipation

Other side effects of gemcitabine include fever Open a glossary item and a rash. Other side effects of paclitaxel include an allergic reaction to the drug and hair loss.

There is more information about the side effects of gemcitabine, paclitaxel and vinflunine on CancerHelp UK.