
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called nab-paclitaxel with either gemcitabine or carboplatin for triple negative breast cancer. If breast cancer doesn’t have receptors for the hormones progesterone and oestrogen, or for the protein HER2, it is called triple negative breast cancer
Doctors usually treat breast cancer with surgery. You may also have other treatments such as chemotherapy to try to stop the cancer coming back in the breast or spreading to another part of your body.
But sometimes breast cancer does spread somewhere else in the body. This is called secondary or metastatic breast cancer.
Some of the treatments that doctors can use to treat metastatic breast cancer, such as hormone therapy or a drug called Herceptin don’t work for triple negative breast cancer. So if this type of cancer spreads somewhere else in the body, you are most likely to have chemotherapy. The chemotherapy drugs that doctors may use include gemcitabine, carboplatin and paclitaxel (also known as Taxol).
One type of paclitaxel is combined with a protein called albumin to form a drug called nab-paclitaxel (also known as Abraxane). This form of the drug can be given at a higher dose and it may work differently to Taxol.
In this trial, researchers are looking at nab-paclitaxel alongside either gemcitabine or carboplatin. They are comparing these drug combinations with a combination of gemcitabine and carboplatin. The women taking part have not had any other treatment for breast cancer that has spread, so doctors call this .
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This is an international trial that will recruit nearly 800 women in a number of different countries. The trial is in 2 parts.
The 1st part of the trial will recruit about 240 women. The aim of this part is to find which of the drug combinations containing nab-paclitaxel is best. It is a randomised trial. The women taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Everybody taking part has 3 week cycles of treatment. You have 2 drugs through a drip into a vein in the 1st and 2nd week of each cycle. The 3 different treatments are
The 2nd part of the trial will recruit about 550 women. The aim of this part is to look at the best drug combination containing nab-paclitaxel that the researchers found in the 1st part of the trial and compare it with the combination of gemcitabine and carboplatin. This part of the trial is also randomised, but the women will be put into 1 of 2 groups. Depending on results from the 1st part of the trial, you have 1 of the following
As long as you don’t have bad side effects, and you don’t need to have surgery or radiotherapy, you can carry on having treatment for as long as both you and your doctor think it is helping you.
If you join the 2nd part of the trial, the trial team will ask you to fill out a questionnaire before you start treatment, every 3 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start treatment. The tests include
During the trial, you go to hospital twice in each 3 week cycle of treatment. You have regular blood tests. You have a CT scan every 6 weeks. You may need to have more bone scans.
When you finish treatment, you see the trial team again about 4 weeks later. After that a member of the team will contact you by phone every 3 months to see how you are and whether you have started any other treatment.
If you stop the trial treatment for any reason other than your cancer getting worse, the trial team will ask you to carry on having scans every 6 weeks unless your cancer does start to get worse.
The most common side effects of nab-paclitaxel include
The most common side effects of carboplatin include
The most common side effects of gemcitabine include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Robert Coleman
Celgene
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”