A study looking at chemotherapy and biological therapy to treat breast cancer in older people

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 study is looking at giving 2 types of biological therapy and 1 type of chemotherapy to people over the age of 60 who have breast cancer. It is for people whose breast cancer has spread beyond their breast (called advanced or stage 4 breast cancer). The cancer must be HER 2 Open a glossary item positive.

More about this trial

Doctors know from research which drugs are best to treat younger people who have breast cancer. But there is no good evidence on the best treatment for older people.  Decisions about treatment and which drugs to use is often based on the opinion of the cancer specialist.

In this study doctors want to find how well 2 types of drug treatment might work for advanced breast cancer. They are

  • Herceptin (trastuzumab) and pertuzumab (PH)
  • Herceptin, pertuzumab and metronomic cyclophosphamide (PHM)

Herceptin and pertuzumab are both biological therapy drugs called monoclonal antbodies. They both target HER 2 but work in slightly different ways and so are often given together as a treatment for HER 2 positive breast cancers. Cyclophosphamide is a chemotherapy drug. Metronomic cyclophosphamide is a milder version of the drug which you take as a tablet.

If your cancer gets worse while you are having either of the treatments, the doctors will offer you another treatment. This is a new drug called trastuzumab-DM1 which also targets the HER 2 cells.

The aims of this study are

  • To see if the drugs work for older people with advanced breast cancer
  • Learn about the side effects of the treatment
  • See how treatment affects people’s quality of life Open a glossary item

Who can enter

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

  • You have been diagnosed with a stage 4 breast cancer or have breast cancer that has come back after surgery and is now stage 4
  • Your breast cancer is HER 2 positive
  • Your cancer can be measured or assessed using scans, X-rays or other tests
  • You have satisfactory blood test results
  • You are well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3)
  • You are aged 70 or older or over the age of 60 and have certain health problems (your doctors can advise you about this)
  • If you are a man and there is a possibility that your partner could become pregnant you must be willing to use contraception during the study and for up to 6 months afterwards.

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

  • Have cancer spread to the brain which is causing symptoms. If you have had treatment for cancer spread to the brain in the past then this must have finished at least 2 months before starting the study treatment
  • Have had chemotherapy for advanced breast cancer. If you had chemotherapy after surgery this must have been completed at least 6 months ago
  • Have had pertuzumab
  • Have had more than 1 course of Herceptin (trastuzumab) or lapatinib with hormone therapy
  • Have had the maximum dose of a type of chemotherapy drug called an anthracycline Open a glossary item
  • Have had an experimental treatment in the last 4 weeks
  • Have had radiotherapy for your symptoms (palliative radiotherapy) in the last 2 weeks
  • Have had surgery in the last 4 weeks or will need surgery during the time of the study
  • Have had a major injury in the last 4 weeks
  • Have had any cancer in the last 5 years apart from carcinoma in situ of the cervix or basal cell or spinocellular skin cancer
  • Have high blood pressure that is not controlled by medication
  • Have certain problems with your heart such as problems with your heart rhythm, a lack of blood flow to the heart, a heart attack in the last 6 months or angina that needs treatment (your doctors can advise you about this)
  • Have numbness and tingling in your hands and feet (peripheral neuropathy) that your doctor thinks is a cause for concern
  • Have any condition that affects your whole body that is not being controlled by medication such as diseases of the lung or diabetes
  • Have a condition which prevents wound healing
  • Have ulcers or a bone fracture
  • Have HIV or active hepatitis B or C
  • Have had an allergic reaction to Herceptin (trastuzumab)
  • Have any other condition or mental health problem that the doctors think would affect your taking part in this study

Trial design

This is a phase 2 international study. The doctors need around 20 people in the UK to take part. It is a randomised study. 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. You will be put into one of the following

  • Herceptin (trastuzumab) and pertuzumab (PH)
  • Herceptin, pertuzumab and metronomic cyclophosphamide (PHM)

You have Herceptin and pertuzumab through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. If you are in the group having cyclophosphamide you have this once a day.

You have treatment until your breast cancer starts to grow again or you cannot manage the side effects. If this happens the doctors will offer you a new drug called trastuzumab-DM1. You have this drug as a drip into the vein once every 3 weeks. You have it for as long as it is keeping the breast cancer under control, you can manage any side effects and both you and your doctors think it is the right treatment for you.

As part of the study the doctors will ask if you will be willing to give 4 extra blood samples. They will use these samples to learn more about breast cancer and other diseases. They will also look for biomarkers Open a glossary item. Doctors hope that in the future these might help them know who will benefit best from treatment.

You do not have to give these extra blood samples if you don’t want to, you can still take part in the study.

The trial team will ask you to fill out a questionnaire

  • When you start the study
  • At 9 weeks, 27 weeks and 1 year after you start the study

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

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

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

You go to hospital once every 3 weeks for your treatment. After you have the drugs you need to stay in the hospital for up to 1 hour to check for any side effects. Then you can go home.

You have a heart scan and a CT or MRI scan every 9 weeks while you are having treatment.

If you go on to have trastuzumab-DM1 you have a heart scan and either a CT or MRI scan. You have treatment every 3 weeks. After you have the drug you need to stay in the hospital for up to 30 minutes to check for any side effects, then you can go home.

After you have finished treatment on the study you see the doctors 1 month later. The doctors will ask how you are and you may have a heart trace or heart scan. The study team then contact you every 3 months to see how you are.

Side effects

The most common side effects of Herceptin and pertuzumab when you have them together are

Because the dose of cyclophosphamide used in this study is low the following side effects are occasional rather than common

The most common side effects of trastuzumab-DM1 include

  • Constipation
  • Feeling sick
  • Loss of appetite
  • Cough
  • Breathlessness
  • Tiredness(fatigue)
  • Lack of iron in your blood (anaemia)
  • Pain (headache, back pain, or joint pain)
  • Urine infection
  • Bruising

We have more information on

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 David Cameron

Supported by

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12876

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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