“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A study looking at pertuzumab for HER2 positive breast cancer that has spread (PERUSE)
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 study is looking at pertuzumab and trastuzumab (Herceptin) with a taxane chemotherapy drug for breast cancer that is HER2 positive. The taxane chemotherapy drug could be one of the following
This study is open to women and men whose breast cancer has spread into surrounding tissue (
) or to another part of their body (secondary breast cancer).
Doctors can treat breast cancer that has spread or come back and is HER2 positive with trastuzumab and a taxane chemotherapy drug. This combination works but they are always looking for ways to improve treatment.
Pertuzumab is a type of biological therapy called a monoclonal antibody. Monoclonal antibodies seek out cancer cells by looking for a particular protein.
We know from research that the combination of pertuzumab and trastuzumab with docetaxel works for HER2 positive advanced breast cancer.
The aims of this study are to find out
- More about the side effects of the combination of pertuzumab, trastuzumab and a taxane chemotherapy drug
- How well this combination works
- How well people cope with this combination
- How safe this combination is
Who can enter
You may be able to enter this study if
- You have breast cancer that has spread into the surrounding tissue, spread to another part of your body, or has come back in the same place and you can’t have surgery to try and cure it
- You have breast cancer that has large amounts of the HER2 protein
- You have at least 1 area of cancer that can be measured as part of this trial
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Your heart works well enough – your doctor will test for this
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 6 months afterwards, apart from any containing hormones such as the pill – your doctor can advise about this
- You are at least 18 years old
You cannot enter this study if
- Your cancer has spread to your brain or spine, can be seen on a scan and your symptoms aren’t well controlled or you are taking steroids to control symptoms – you may be able to take part if you have had treatment for your cancer spread and it has been stable for the past 3 months
- You have had chemotherapy or biological therapy for your cancer spread or locally advanced breast cancer – if you had everolimus with a hormone therapy you may be able to take part
- You have had more than 2 different types of hormone therapy to treat cancer that had come back in the same place or that had spread
- After finishing chemotherapy or biological therapy your cancer came back within 6 months
- You have had anti HER2 treatment for
early breast cancer apart from trastuzumab (Herceptin) or lapatinib
- You had an ongoing problem of moderate to severe drop in blood cells after treatment for your breast cancer
- You have severe
nerve damage
- You have had another cancer in the past 5 years apart from in situ carcinoma of the cervix or
basal cell skin cancer - You have high blood pressure that isn’t controlled
- You have had a stroke or heart attack in the past 6 months or any other serious heart problem
- You are HIV, hepatitis B or hepatitis C positive
- You have difficulty breathing as a result of your cancer or need to use oxygen at home for any reason
- You have had major surgery or a major injury in the past 2 weeks
- You have had antibiotics through a
drip into a vein in the past week - You have been taking a daily dose of 10 mg or more of steroids for the past 3 months apart from inhalers
- You have any other medical condition that could affect you taking part in this trial
- You are allergic to the drugs used in this trial, similar drugs or their ingredients
- You have had an experimental treatment as part of another clinical trial in the past month
- You are pregnant or breastfeeding
Trial design
This is an international phase 3 study. It will recruit 1,500 people from different countries around the world.
Everyone taking part will have pertuzumab and trastuzumab alongside a taxane chemotherapy drug. The taxane drug could be docetaxel, paclitaxel or nab-paclitaxel. You have all of these as a drip into a vein. You may have them as a drip into a central line, PICC line or portacath. You have them every 3 weeks. You can continue treatment as long as it is helping you and the side effects aren’t too bad.
For the women who take part in this study, the team will ask you to fill out a questionnaire before you start treatment and then every 9 weeks during treatment, a month after treatment and then every 3 months. 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 study. These tests include
- A physical examination
- CT scan or MRI scan
- Heart trace (
ECG ) - Heart scan (
ECHO or MUGA ) - Blood tests
- Bone scan – if needed
During treatment you see the doctor every 3 weeks for a physical examination and blood tests. Every 9 weeks you have a
- CT scan or MRI scan
- Heart trace
- Heart scan
- Bone scan – if needed
After treatment you see the doctor every 3 months. If your cancer didn’t get worse during treatment you will also have a scan.
Side effects
The most common side effects of pertuzumab and trastuzumab are
- Diarrhoea
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Fever
- Tiredness
- Skin rash
- Headache
- Sore mouth
- Loss of appetite and taste changes
- Changes to your nails
- Sore muscles and joints
- Muscle weakness and loss of strength
- A change to the way your heart works
- A change to the way your lungs work
- An allergic reaction causing a change in blood pressure, difficulty breathing, wheezing, shaking, hot flushes and swelling of the face and neck - staff will monitor you and will be able to treat you if this happens
The most common side effects of paclitaxel, nab-paclitaxel and docetaxel drugs are
- Hair loss
- Swelling of the ankles and feet
- A drop in blood cells
- Numbness, tingling and pain in the hands and feet
- Feeling or being sick
- Constipation or diarrhoea
- An allergic reaction causing fever, chills, low blood pressure, shortness of breath, headache, flushing and skin rash
Your doctor will talk to you about the possible side effects before you agree to take part in this trial.
We have more information about trastuzumab, pertuzumab, docetaxel, paclitaxel and nab-paclitaxel in our cancer drugs section.
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 David Miles
Supported by
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Roche
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Oracle 9440
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
