A trial looking at trastuzumab and pertuzumab for HER2 positive breast cancer - APHINITY
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding a new drug called pertuzumab to trastuzumab (Herceptin) for people who have had surgery for breast cancer. It is for people whose breast cancer is HER2 positive. This means the breast cancer cells have tested positive for a protein called HER2.
Doctors often treat HER2 positive breast cancer with surgery followed by chemotherapy then trastuzumab. Trastuzumab is a type of biological therapy called a monoclonal antibody. It works by targeting and blocking the HER2 protein on the cancer cell.
Pertuzumab is a monoclonal antibody that works with trastuzumab in targeting the HER2 protein. Information from research so far suggests that giving both these drugs together for HER2 positive breast cancer may be better than just giving one.
The aim of this trial is to find out if giving pertuzumab with trastuzumab is better than trastuzumab alone for people who have had surgery for HER2 positive breast cancer. And to find out more about the side effects of this combination of treatments.
Who can enter
You may be able to enter this trial if
- You have a stage 1, 2 or 3 breast cancer that is HER2 positive
- Your cancer has spread to your
lymph nodes 
- You have either had surgery to remove your whole breast (mastectomy) or surgery to remove a lump from your breast (wide local excision)
- You had your breast surgery at least 3 weeks and no more than 7 weeks before starting the trial treatment
- You are well enough to carry out your normal activities apart from heavy physical work (performance status 0,1)
- You have satisfactory blood tests results
- Your heart works well enough – your doctor will test for this
- You are willing to use reliable contraception during treatment and for 6 months after if there is any chance that you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have stage 4 breast cancer
- Have had breast cancer before
- Have had chemotherapy or radiotherapy before
- Have had biological therapies or
immunotherapy before - Are having anti cancer treatment as part of another clinical trial
- Have had another cancer in the last 5 years apart from carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell skin cancer or squamous cell skin cancer – you may be able to join the trial if you had cancer more than 5 years ago and it was successfully removed with surgery
- Have heart failure
- Have a serious problem with the rhythm of your heart that is not well controlled
- Are taking medication for heart pain (angina)
- Have high blood pressure that is not well controlled
- Have another serious condition that could affect you taking part in this trial
- Are sensitive to the medications used in this trial or any of their ingredients
- Are pregnant or breastfeeding
Trial design
This is a phase 3 international trial. It will recruit about 3,800 people from around the world.
This is a randomised trial. You will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
If you are in group 1 you have chemotherapy, trastuzumab and pertuzumab.
If you are in group 2 you have chemotherapy, trastuzumab and a dummy drug ().
Your doctor will choose which chemotherapy is best for you.
You have trastuzumab and pertuzumab, or the dummy drug, as a drip into a vein. You have treatment every 3 weeks. This is called a cycle of treatment. You can have up to 18 cycles of treatment in total.
You have trastuzumab for the first time over 90 minutes. You have a 30 minute break to make sure you don’t have a reaction to it. You then have pertuzumab, or the dummy drug, over 60 minutes. You have another 60 minute break to make sure you don’t have a reaction to it.
If you have no problems with trastuzumab and pertuzumab, you can have them over a shorter time with a shorter observation period afterwards.
You fill in 3 questionnaires before you start treatment, during treatment, at the end of treatment and then at 18 months, 2 years and 3 years. They will ask you how you have been feeling and about any side effects you have had from your treatment. This is called a quality of life study.
The researchers will ask permission to store some tissue samples from when you had your breast surgery. They will also ask to store some blood samples. By studying these samples they hope to learn more about how trastuzumab and pertuzumab works and how it affects the body. You don’t have to give permission for this if you don’t want to. You can still take part in the main trial.
Hospital visits
You will see the doctor and have some tests before taking part in this trial. These tests may include
- A physical examination
- Blood tests
- Heart trace –
ECG
- Heart scan –
ECHO or MUGA
- Chest X-ray
- Mammogram
- CT scan, MRI scan, PET scan or bone scan
During treatment you see the doctor every 3 weeks for a physical examination and blood tests. You will also have a heart scan at regular times during your treatment.
About 1 month after treatment you see the doctor for a physical examination and blood tests.
You then see the doctor
- Every 3 months for a year
- Every 6 months for 3 years
- Then once a year for 6 to 9 years
Side effects
The most common side effects of trastuzumab and pertuzumab are
- Diarrhoea
- Fever
- Chills
- Low blood pressure
- Shortness of breath
- Rash
- Headache
A less common side effect of trastuzumab is that it can cause the heart not to pump as well as it should. Doctors call this heart failure. The symptoms of heart failure may include breathlessness, tiredness, swelling of the ankles or feet and constant coughing. Pertuzumab may also affect the way your heart works. Your doctor will check your heart regularly while you are having treatment. If they are concerned, they may stop your treatment for a short period of time or if necessary stop it completely.
You can find more information about chemotherapy for breast cancer in our breast cancer section. There is more information about trastuzumab and pertuzumab 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.
Chief Investigator
Professor David Cameron
Supported by
Breast International Group (BIG)
Experimental Cancer Medicine Centre (ECMC)
Genentech Ltd
National Institute for Health Research Cancer Research Network (NCRN)
Roche
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
