A trial looking at pertuzumab, trastuzumab and an aromatase inhibitor for breast cancer that has spread (PERTAIN)

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 combining pertuzumab with trastuzumab and a hormone therapy called an aromatase inhibitor to treat breast cancer that has spread. This trial is open to women who have breast cancer that is HER 2 receptor positive, hormone receptor positive and has spread into the surrounding tissue (locally advanced) or to another part of the body (secondary breast cancer).

Trastuzumab (Herceptin) is a biological therapy drug called a monoclonal antibody. It seeks out cancer cells by looking for a particular protein. Aromatase inhibitors are hormone therapy drugs. They work by blocking an enzyme called aromatase which the body can use to make oestrogen.

This combination of drugs can work well for breast cancer that is locally advanced or has spread, and is positive for HER 2 receptors and hormone receptors. But doctors are always looking for ways to improve treatment.  

Pertuzumab is another type of monoclonal antibody. It too looks for a particular protein on the cancer cell but works in a slightly different way to trastuzumab.  

The researchers think that adding pertuzumab to the combination of trastuzumab and an aromatase inhibitor may work better than having them alone.

The aim of this trial is to compare the combination of pertuzumab, trastuzumab and an aromatase inhibitor with trastuzumab and an aromatase inhibitor to find out which combination works best for breast cancer that is locally advanced or has spread. They also want to find out how safe the combination of pertuzumab, trastuzumab and an aromatase inhibitor is and what the side effects are.

Who can enter

You may be able to enter this trial if

  • You have breast cancer that has spread into surrounding tissue (locally advanced) or to another part of your body (secondary breast cancer)
  • You have breast cancer that is HER2 positive
  • You have cancer that is hormone receptor positive
  • Your periods have stopped completely (you are post menopausal)
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Your heart works well enough – your doctor will test for this
  • You have satisfactory blood test results
  • You are at least 18 years old

You cannot enter this trial if

  • You have breast cancer that doctors can remove with surgery to try and cure it
  • You have had chemotherapy or a biological therapy before and your breast cancer came back within 6 months of finishing treatment
  • You have had chemotherapy or a biological therapy for locally advanced breast cancer or breast cancer that has spread
  • You have already had treatment with ganetespib, pertuzumab or saracatinib, including as part of another clinical trial
  • Your cancer continued to grow while having trastuzumab or lapatinib
  • You have cancer that has spread to your brain that can be seen on a scan and you have symptoms or you need to have continuous steroids to control symptoms – if you have had radiotherapy or surgery to treat cancer spread to the brain and you have no symptoms you may be able to take part
  • You have ongoing low levels of blood cells as a side effect from previous cancer treatment
  • You have severe nerve damage
  • You have had another cancer in the past 5 years apart from in situ carcinoma of the cervix and basal cell carcinoma
  • You have high blood pressure that isn’t controlled with medication
  • You have had a stroke or heart attack in the past 6 months or any other serious heart problem
  • You have had major surgery or major injury in the past 2 weeks
  • You are short of breath when resting or need to use oxygen continually
  • You are HIV, hepatitis B or hepatitis C positive
  • You need to have antibiotics through a drip (intravenous) in the week before being put into your treatment group for this trial
  • You are not able to take tablets for any reason
  • You are taking 10 mg or more of steroid tablets a day
  • You are allergic to the drugs used in this trial, or similar drugs, and their ingredients
  • You have had an experimental drug as part of another clinical trial in the past month or are taking part in another clinical trial
  • You have any other condition that could affect you taking part in this trial

Trial design

This is an international phase 2 trial. It will recruit a total of 250 women from different countries around the world including about 20 women from the UK. It is a randomised trial. The women taking part are put into 1 of 2 treatment groups. Neither you nor your doctor can choose which group you are in.  

The 2 groups are

  • Pertuzumab, trastuzumab and an aromatase inhibitor
  • Trastuzumab and an aromatase inhibitor

As a part of your treatment, your doctor may decide to give you docetaxel or paclitaxel chemotherapy before you start your aromatase inhibitor. Your doctor will talk to you about this beforehand.  

PERTAIN trial diagram

You have pertuzumab and trastuzumab as injections into a vein. If you are having both drugs for the first time, you have pertuzumab on the first day and trastuzumab on the next day. After the first time you may have them on the same day. You have them every 3 weeks.

Aromatase inhibitors are tablets. You take them every day. Your doctor or nurse will tell you how to take them.

You continue to have pertuzumab, trastuzumab and the aromatase inhibitor as long as they are helping you and the side effects aren’t too bad.  

If are having docetaxel you have it every 3 weeks for 18 to 24 weeks. If you are having paclitaxel you have it every week for 18 to 24 weeks.You have these as an injection into a vein.

The trial team will ask you to fill out a questionnaire before you start treatment, then every 9 weeks during and after your treatment. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

Hospital visits

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

  • A physical examination
  • Blood tests
  • CT scan or MRI scan
  • Bone scan – if needed
  • Heart trace (ECG)
  • Heart scan (ECHO or MUGA)

During treatment you see the doctor every 3 weeks for a physical examination, blood tests and to see how you are. Every 9 weeks you have a heart trace, a heart scan, CT scan or MRI scan and bone scan if needed.

After finishing treatment you see the doctor a month later for a physical examination, blood tests and a CT scan or MRI scan. You then see the doctor every 3 months to see how you are.

Side effects

The most common side effects of pertuzumab and trastuzumab are

The most common side effects of aromatase inhibitors include

  • Bone thinning
  • Joint stiffness or pain
  • High cholesterol in the blood

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

We have information about the side effects of docetaxel and paclitaxel in our cancer drugs section.

We have more information about trastuzumab and pertuzumab in our cancer drugs section.

We have more information about aromatase inhibitors on our hormone therapy for secondary breast cancer page.

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 Peter Schmid

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9035

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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