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

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 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 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 )
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 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.

Women in one group have cabazitaxel
Women in the other group have paclitaxel

CONCEPT trial diagram

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 )
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.