A trial looking at cabazitaxel for HER2 negative breast cancer that has spread (CONCEPT)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 2

This trial is looking at a new drug called cabazitaxel for women with breast cancer that has spread to another part of the body. It is for women whose breast cancer cells have low or no amounts of HER2 Open a glossary item. This is called HER2 negative breast cancer.

More about this trial

Women with HER2 negative breast cancer do not benefit from certain types of biological therapy such as Herceptin (Trastuzumab). This means they have fewer treatment choices.

Doctors can use chemotherapy to treat HER2 negative breast cancer that has spread. One of the chemotherapy drugs they use is called paclitaxel. This works well, but doctors are always looking for ways to improve treatment. In this trial they are looking at a chemotherapy drug called cabazitaxel (also known as Jevtana).

The researchers are comparing cabazitaxel with paclitaxel. The main aims of this trial are to find out

  • If cabazitaxel works better than paclitaxel for women with HER2 negative breast cancer that has spread to another part of the body
  • More about the side effects and how these affect quality of life

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have breast cancer that is HER2 negative Open a glossary item and has spread to another part of your body
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for 1 year afterwards if there is any chance you or your partner could become pregnant. You can’t use any contraceptives that contain hormones, such as the pill  (your doctor can advise about this)
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have breast cancer that has spread to your brain or spinal cord
  • Have had paclitaxel chemotherapy in the past
  • Have already had chemotherapy for cancer that spread to another part of your body (if you had chemotherapy for early breast cancer and it was completed at least 3 months ago you may be able to take part)
  • Have had radiotherapy to help with your symptoms (palliative radiotherapy) in the last 4 weeks
  • Are having hormone therapy (you may be able to take part in the trial if you stop taking this, but it is important that you don’t stop any other treatment before discussing it with your doctor)
  • Have nerve damage affecting your hands or feet (peripheral neuropathy) unless it is only mild
  • Have a very sore mouth (mucositis Open a glossary item)
  • Have a serious infection that is being treated with antibiotics or antifungal treatment
  • Have had another cancer in the past apart from non melanoma skin cancer that was successfully treated
  • Have had an experimental drug as part of another clinical trial in the last month
  • Have had a stroke, heart attack or unstable heart pain (angina) in the last 6 months
  • Have any other serious heart problem
  • Have had high blood pressure in the past or have high blood pressure that isn’t well controlled with medication
  • Have had a vaccination Open a glossary item with a live virus in the last 2 months
  • Are having treatment with drugs such as ketoconazole, itraconazole or clarithromycin (unless you stop this when you take part in the trial but it is important that you don’t stop any other treatment before discussing it with your doctor)
  • Can’t have steroid treatment
  • Are known to be very sensitive to any of the drugs in the trial
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are pregnant or breast feeding

Trial design

This is a phase 2 trial. The researchers need 90 women to take part. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone has 3 week cycles of treatment. If you have cabazitaxel, you have treatment once every 3 weeks. It takes about an hour each time. If you have paclitaxel, you have treatment every week.

You have cabazitaxel or paclitaxel as a drip into a vein. As long as you don’t have bad side effects and your cancer doesn’t get worse, you have up to 6 cycles of treatment in total. This will take about 18 weeks.

A small study is looking at circulating tumour cells. These are cancer cells that break away and travel in the bloodstream. The researchers want to find out whether circulating tumour cells can help to predict how well treatment will work for HER2 negative breast cancer that has spread. This is called a sub study and it is only for patients taking part in the trial in Bristol. If you join the sub study, you have 4 extra blood tests. It is up to you whether you want to be part of the sub study. If you don’t want to, you can still take part in the main trial.

The trial team will ask everybody taking part in the trial to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.

Hospital visits

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

  • Blood tests
  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • MRI or CT scan

You may also have a bone scan.

You go to the hospital to have your chemotherapy either once a week or once every 3 weeks (depending on which group you are in). You also go to hospital before each chemotherapy treatment to discuss any side effects with your doctor and have some blood tests.

If you are having cabazitaxel, you have injections with a growth factor drug after each treatment. Growth factors stimulate the bone marrow to make certain blood cells. In this trial you have G-CSF. This is to reduce the chance of infections. You don’t need to go to hospital for this. You or a friend or relative can be taught to give the injection. Or a nurse can visit you at home to give you this drug.

You have a CT scan of your chest, tummy (abdomen) and the area between your hip bones (pelvis) every 6 weeks until you finish treatment.

You will see the trial team about 4 weeks after you finish treatment, 3 months later and then 6 months after that.

Side effects

The most common side effects of cabazitaxel and paclitaxel are

Location

Bath
Blackpool
Bristol
Cardiff
Exeter
London
Newcastle upon Tyne
Nottingham
Plymouth
Taunton
Truro
Worcestershire

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Amit Bahl

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sanofi Aventis
University Hospitals Bristol NHS Foundation Trust

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12650

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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