A trial comparing different chemotherapy drugs for advanced triple negative breast cancer (TNT trial)

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 looking at 2 different chemotherapy drugs for breast cancer that doesn’t have receptors for oestrogen, progesterone or HER2. This type of breast cancer is called triple negative breast cancer. Women can also take part if they have advanced breast cancer and have a known gene fault called a BRCA gene mutation, whether or not they have any of the receptors. This trial is supported by Cancer Research UK.

Some of the treatments that doctors often use for breast cancer, such as hormone therapy or Herceptin, don’t work for triple negative breast cancer. So after surgery, chemotherapy is the main treatment for this type of cancer.

In this trial, the researchers are looking at triple negative breast cancer that has spread to other parts of the body or has come back after treatment.

Docetaxel is a chemotherapy drug that doctors often use to treat breast cancer that has spread. But some recent research carried out in the laboratory has suggested that a drug called carboplatin may work better for triple negative breast cancer.

The aim of the trial is to see if carboplatin can slow down the growth of triple negative breast cancer better than docetaxel.

Who can enter

You can enter this trial if you

Have triple negative breast cancer or you have breast cancer and have a BRCA gene mutation
Have breast cancer that has spread to other parts of the body or has come back after earlier treatment and your doctors think you are suitable for treatment that includes a taxane chemotherapy drug
Are well enough to take part (performance status 0, 1 or 2)
Have satisfactory blood test results
Are willing to use a reliable method of contraception during the trial, and for 6 months afterwards, if there is any chance that you could become pregnant

You cannot enter this trial if you

Have breast cancer that is oestrogen receptor positive , progesterone receptor positive or HER2 positive
Have metastatic breast cancer that has spread only to your bones or only to your brain
Have locally advanced breast cancer that your doctors can treat with radiotherapy or anthracycline chemotherapy (this will only be possible if you didn’t have anthracycline chemo after surgery when you first had breast cancer (adjuvant treatment)
Have already had chemotherapy for breast cancer that has come back, other than anthracycline chemotherapy
Have had adjuvant treatment that included a taxane chemotherapy drug in the last 12 months
Have already had a platinum chemotherapy drug
Have or have had another type of secondary breast cancer
Have bad nerve damage (neuropathy) from earlier treatment
Are allergic to platinum or mannitol
Are known to be sensitive to taxane drugs
Have had any other type of cancer, apart from non melanoma skin cancer or carcinoma in situ of the cervix that has been successfully treated, or another cancer that has been in complete remission for at least 10 years
Have another medical condition that cannot be controlled with medicine and may affect you taking part in the trial
Are pregnant or breastfeeding

Trial design

This is a randomised trial. Between 370 and 450 women will take part. They are put into one of 2 treatment groups at random. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part will have chemotherapy in 3 week cycles of treatment. You have the chemotherapy through a drip into a vein on the first day of each cycle. The treatment will take about an hour each time.

If you are in group 1, you have carboplatin. If you are in group 2, you have docetaxel. People having docetaxel also have steroid tablets 1 day before and 2 days after the chemotherapy, to reduce the risk of having a reaction to the drug. And they have daily injections of blood cell growth factors for up to 7 days following chemotherapy to boost the number of white blood cells made by the body.

After the first 3 cycles of treatment, you have a CT scan to see if the cancer has got smaller, stayed the same size or grown. If it has stayed the same or got smaller, you have another 3 cycles of the same treatment.

If your cancer has grown, you will swap to the other drug. So, if you are in group 1, and your cancer has grown after 3 cycles of carboplatin, you will stop having carboplatin and start treatment with docetaxel. You may change treatment earlier if your doctors think your cancer has grown (or you have serious side effects) before you have completed the first 3 cycles.

If you change treatment, you can have up to 6 cycles of treatment with the other drug, but you will have another CT scan after 3 cycles. If your cancer is still growing, you will stop having the trial treatment and your doctor will discuss other treatment options with you.

If the CT scan after 3 cycles showed the cancer was the same or smaller, but the scan after 6 cycles shows the cancer has grown, you can then have the other treatment. You will have a scan after 3 cycles to check it is helping you. If it is, you will have 3 more cycles. So, you could have up to 12 cycles of treatment in total.

Before you start treatment, the trial team will ask you for an extra blood sample. They will also ask your permission to get samples of tissue taken when you had surgery to remove your breast cancer. This is because studying blood and tissue samples may help them to learn more about triple negative breast cancer. They may also ask if they can take another biopsy Open a glossary item . If you agree to have this, it will take about an hour and you will have a local anaesthetic.

The researchers will look at the DNA in your blood and tissue samples. Then the samples will be stored safely and may be used in the future, but only for research purposes. If you do not want to give these extra samples for research, you don’t have to. You can still take part in the trial.

The researchers will ask you to fill in a short questionnaire about your family history. This will ask about any other family members who have had cancer. It will take 10 to 20 minutes to complete.

Hospital visits

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

Physical examination
Blood tests
CT scan
MRI scan
Bone scan
Chest X-ray
Heart trace (ECG )
A pregnancy test

You go to the hospital once every 3 weeks to have chemotherapy. During your treatment you will have regular blood tests and a CT scan after every 3 cycles of treatment.

You will have another CT scan 4 weeks after you finish your treatment. Then you will see the doctors and have a CT scan every 3 months for 3 years.

Side effects

General side effects of chemotherapy include

Feeling or being sick
Loss of appetite
Feeling tired or weak
A drop in blood cells causing an increased risk of infection, bruising or bleeding problems, tiredness and breathlessness

There is more information about the possible side effects of docetaxel and carboplatin on CancerHelp UK.

Recruitment start:

16/01/2008

Recruitment end:

28/02/2014

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.

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Chief Investigator

Prof Andrew Tutt

Supported by

Breakthrough Breast Cancer
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
King's College London
NIHR Clinical Research Network: Cancer