A trial comparing different ways of deciding on treatment after surgery, different types of chemotherapy and different types of hormone therapy for breast cancer (MINDACT)

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:

Other

This trial is looking at 2 different ways for doctors to work out who needs to have more treatment after surgery for breast cancer . It is also looking at different chemotherapy regimes for women who are at high risk of breast cancer coming back. And at different types of hormone therapy for women who have hormone receptor positive breast cancer. This trial is supported by Cancer Research UK.

The first treatment for breast cancer is usually surgery. As well as removing the cancer from your breast, the surgeon also removes some lymph nodes from under your arm. The lymph nodes and the tumour from your breast are looked at under the microscope.

The appearance of the cells (the grade), along with the size of the tumour, whether there are cancer cells in the lymph nodes and whether or not the cells have hormone receptors, give doctors information about how likely it is your breast cancer will come back. If they think there is a high risk, they will offer you treatment with chemotherapy to reduce this risk. This is called adjuvant treatment. If there are hormone receptors on the cells, they will advise you to have hormone therapy .

In this trial researchers are looking at a new way of testing breast cancer cells to see if you should have adjuvant treatment. The test involves looking at the genes in the cancer cells to see which ones are active. This method is called ‘genomics’. It is not a test to see if breast cancer might run in your family. It is only looking at the genes in the cancer cells. The researchers want to find out if this test is better than the tests they currently use.

For women who do have adjuvant chemotherapy, doctors often use a drug called doxorubicin. This can cause long term side effects, including damage to the heart. Other chemotherapy drugs can also work against breast cancer and may have fewer side effects. So, women taking part who have chemotherapy will be asked to join another part of the trial comparing different combinations of chemotherapy drugs.

The trial is also looking at different types of hormone therapy for women who have hormone receptor positive breast cancer. Doctors want to find out if it better to have tamoxifen followed by letrozole or to have just letrozole.

The aims of the trial are to

  • See if genetic tests on cancer cells are better for deciding who needs to have adjuvant treatment than current ways of testing
  • Find which combination of chemotherapy drugs works best after surgery for early breast cancer
  • See if it is better to have tamoxifen and letrozole or letrozole alone after surgery for hormone receptor positive breast cancer

Who can enter

You can enter this trial if you

  • Have been diagnosed with early breast cancer
  • Have a tumour that is T1 or T2, or a T3 tumour that can be surgically removed
  • Have no more than 3 lymph nodes that contain cancer cells
  • Have satisfactory blood test results
  • Are well enough to take part in the trial (performance status 0 or 1)
  • Are willing to use reliable contraception, while you are taking any drugs as part of the trial, if there is a chance you could become pregnant
  • Are between 18 and 70 years of age

You cannot enter this trial if you

  • Have had any other 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 5 years
  • Have had chemotherapy, radiotherapy or hormone therapy in the past
  • Have heart problems
  • Have another serious medical condition that cannot be controlled with medicine
  • Have had an experimental drug as part of a clinical trial in the last 4 weeks
  • Are pregnant or breastfeeding

Trial design

Your doctors will ask you to take part in the trial before you have surgery to remove your breast cancer. If you agree, they will take a sample of your breast tumour during surgery and send it to Holland, where the genomics test is done. They will also take an extra blood sample which will be stored and may be used in the future for research purposes.

If your surgeon finds cancer cells in more than 3 lymph nodes, you can’t take part in the rest of the trial. You can ask for the tumour sample to be destroyed. Or you may agree to donate the sample to be used in future research studies.

If they find there are no cancer cells in your lymph nodes or there are cancer cells in no more than 3 nodes, they will ask you to take part in the main part of the trial. The main trial will involve 6,000 women from around Europe.

Your doctors will compare the results of the genomics test with the usual tests. If both show that you have a high risk of breast cancer coming back, your doctors will suggest you have chemotherapy. If both show that you have a low risk of the cancer coming back, you won’t have chemotherapy.

If one way of testing suggests you are at high risk and one suggests you are at low risk, you take part in a randomisation. You will be put into one of two groups by computer. Neither you, nor your doctor will be able to decide which group you are in. For women in group 1, doctors will use the results of the standard tests to decide whether or not you are at high risk and should have chemotherapy. For women in group 2, they will use the results of the genomics test to decide your risk and whether you should have chemotherapy.

It is possible that using the genomics test means fewer women have chemotherapy. This would mean that they are at an increased risk of their cancer coming back. So women who don’t have chemotherapy based on the genomic test result, (but who would have had it according to the usual tests) will be monitored very closely.

If you do have chemotherapy, the doctors may ask you to take part in the next bit of the trial. Again, you will be put into one of two treatment groups by a computer. Neither you, nor your doctor will be able to decide which group you are in.

If you are in group A, you will have docetaxel chemotherapy via a drip into a vein every 3 weeks. And you will have capecitabine chemotherapy tablets to take daily at home for 2 weeks. You then have a week without treatment. Each 3 week period is called a cycle of treatment. You have 6 cycles of treatment all together.

If you are in group B, your treatment will depend on whether or not there were cancer cells in any of your lymph nodes. If there were no cancer cells in any nodes, you have 5 Fluorouracil (5FU), cyclophosphamide, methotrexate and epirubicin or doxorubicin. You have all these chemotherapy drugs via a drip into a vein, but exactly how you have them varies slightly between hospitals. You usually have the drugs every 3 weeks. But some people may have treatment 2 weeks in a row and then have a 2 week rest period before the next treatment. You will have 6 or 8 cycles of treatment.

If there were cancer cells in some of your lymph nodes, you have 5FU, cyclophosphamide and epirubicin every 3 weeks for 3 cycles of treatment. Then you have docetaxel alone every 3 weeks for 3 cycles. So you have 6 cycles of treatment all together.

If tests showed that you have hormone receptor positive breast cancer, the doctors may ask to join the part of the trial comparing different types of hormone therapy. You will be put into one of two treatment groups by a computer.

  • If you are in group 1, you have letrozole tablets once a day for 7 years
  • If you are in group 2, you have tamoxifen tablets once a day for 2 years, then letrozole tablets once a day for the next 5 years

If you have not been through the menopause yet, you also need treatment to stop your ovaries working while you have hormone therapy. There are different ways of doing this and the trial doctor will discuss the options with you.

If you don’t wish to take part in the chemotherapy or hormone therapy studies, your doctors will talk to you about the standard chemotherapy and hormone therapy treatments.

Hospital visits

You will see the doctors and have some tests before you take part in the trial. The tests include

  • Physical examination
  • A mammogram of both breasts
  • Chest X-ray
  • Blood tests

Before you take part in the chemotherapy trial, you will have a heart trace (ECG) and either an echocardiogram or a MUGA scan. Before the hormone therapy trial, you will have an internal examination. And you may also have a cervical smear and a DEXA scan.

If you have chemotherapy, you will go to hospital at least once every 3 weeks for up to 6 months.

Everybody taking part will see the trial team

  • Every 3 months for 2 years
  • Every 6 months for the next 5 years
  • Once a year for at least 3 years after that

Side effects

Common side effects of chemotherapy include

On CancerHelp UK there is more information about the specific side effects of

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

Professor Alastair M Thompson

Supported by

Cancer Research UK
European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUK/07/018. 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 819

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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