A trial looking at trastuzumab to reduce circulating tumour cells from breast cancer (Treat CTC)

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 finding circulating tumour cells from breast cancer and then treating them with trastuzumab (Herceptin). It is open to men and women with breast cancer who have completed their main treatment. And their primary cancer Open a glossary itemhad a low number of the protein HER2 (HER 2 Open a glossary item negative).

More about this trial

If you have HER2 negative breast cancer you don’t have further treatment after your main treatment has finished. Unless your cancer grows in response to the hormones oestrogen or progesterone. Then your doctor will give your hormone therapy.

If your breast cancer has a large number of HER2 proteins (HER2 positive) you will have trastuzumab. Trastuzumab is a type of biological therapy called a monoclonal antibody.

Some people have abnormal cells in their blood. These are called circulating tumour cells (CTCs). Some small studies suggest that people who have been treated for breast cancer and have CTCs in their blood may have a higher risk of their cancer coming back.

Results of other small studies suggest that trastuzumab can reduce the number of CTCs. Researchers think this could help people with HER2 negative breast cancer who would not normally have trastuzumab.

This trial is in 2 parts. The first part is to find men and women who have CTCs in their blood. Those who don’t have CTCs in their blood will take no further part in the trial.

In the 2nd part those who have CTCs in their blood will have either

  • Trastuzumab
  • Follow up by the trial team (observation group)

The trial team will compare these 2 groups to find out if trastuzumab does reduce the levels of CTCs in the blood.

Who can enter

There are 2 parts in this trial. The first is for registration.

You may be able to join the registration part of the trial if all of the following apply

  • You have early breast cancer that has been removed by surgery
  • Your cancer has a low number of the protein HER2 (HER2 negative)
  • Your cancer has been tested for oestrogen receptors Open a glossary item
  • You have completed your chemotherapy and there is no plan for further chemotherapy
  • Your treatment or surgery must be completed at least 3 weeks ago and no more than 12 weeks when you register for the trial
  • You are able to have blood taken for the CTC blood test
  • You are at least 18 years old

You may be able to join the randomised part of the trial if all of the following apply

  • The CTC blood test result shows there are at least 1 CTC in your blood
  • The trial team have confirmed your breast cancer is HER2 negative
  • It is 6 weeks or less from the time you registered for the trial to you being put into a group in this trial
  • Your heart works well enough (the trial doctor will test you for this)
  • Your other blood test results are satisfactory
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant

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

  • Have cancer that has spread to another part of your body
  • Have previously had another breast cancer. If you had cancer in both breast at the same time you may be able to take part if you had it in the past 2 years and both cancers were HER2 negative
  • Have already had treatment with an anti HER2 drug such as trastuzumab or pertuzumab
  • Have had treatment with a biological therapy Open a glossary item or immunotherapy Open a glossary item for your cancer
  • Are having, or had, a bisphosphonate drug such as zoledronic acid
  • Have had radiotherapy to the middle of your chest unless it was to the lymph nodes running up the middle of the chest (internal mammary lymph nodes) around the breast
  • Still have side effects from your treatment
  • Had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer Open a glossary item
  • Have had a stem cell transplant
  • Have certain heart problems (the trial team can advise you about this)
  • Are already taking part in another clinical trial
  • Have any other medical or mental health problem that the trial team think could affect you taking part

Trial design

This is a phase 2 trial. The researchers need 2,175 people to join the registration part and 174 to join the randomised part.

Everyone in the registration part will have blood taken to see if there are any circulating tumour cells (CTC). When the results are available you see the doctor.

If you don’t have CTCs in your blood you will take no further part in the trial. Only people who have CTCs in their blood will go on to the randomisation part.

In the randomised part you will be put into 1 of 2 groups. Neither you or your doctor can choose which group you are in.

  • People in one group will have trastuzumab
  • People in the other group won't have trastuzumab (this called the observation group)

You have trastuzumab as a drip into a vein every 3 weeks. You have a total of 6 doses. You have the trastuzumab over 1½ hours.

After the 1st dose you will stay in hospital for another 6 hours. This is to make sure you don’t have a reaction to trastuzumab.

Diagram for Treat CTC

If you agree to take part in the trial, the researchers will ask for a sample of your cancer from when you had surgery. They will use this to test for the HER2 protein.

Hospital visits

You see the doctor to have some tests before taking part. These tests include

  • A physical examination
  • Blood tests
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)

If you are having trastuzumab, during treatment you see the doctor every 3 weeks to see how you are. At week 9 you have                         

  • A physical examination
  • Blood tests
  • Heart scan

After treatment you see the doctor for the same tests.

If you aren’t having trastuzumab, you see the doctor at 18 weeks for the same tests you had at the start, apart from the heart scan.

Everyone sees the doctor once a year for 2 years to see how you are. If you had trastuzumab you will have a heart scan every year.

Side effects

The most common side effects of trastuzumab are

The trial doctor will talk to you about the possible side effects before you agree to take part in the trial.

We have information about trastuzumab.

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 Anthony Kong

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
NIHR Clinical Research Network: Cancer
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12703

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

A 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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