“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."
A trial of AUY922 with Herceptin for advanced breast cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at AUY922 and Herceptin for breast cancer that has grown outside the breast or spread to other parts of the body and is HER2 positive. This means the breast cancer cells have receptors for a protein called HER2.
Doctors often use Herceptin (also known as trastuzumab) to treat HER2 positive breast cancer. The Herceptin can attach to the HER2 receptors and stop the cancer growing. But sometimes Herceptin does not work very well. This trial is for women whose breast cancer has got worse despite having Herceptin.
We know from research that a drug called AUY922 can stop the activity of proteins that cancer cells need to grow. Doctors hope that if they can stop the proteins working, the cancer cells will die.
Women taking part in this trial have both AUY922 and Herceptin. The aims of the trial are to
- Find the highest safe dose of AUY922 that you can have at the same time as Herceptin
- See if having these 2 drugs together helps people with HER2 positive advanced breast cancer
- Learn more about what happens to the drugs in your body
Who can enter
You can enter this trial if you
- Are a woman and have breast cancer that has grown outside the breast or spread to another part of your body (locally advanced or secondary breast cancer)
- Have cancer that cannot be removed with surgery and is HER2 positive
- Have had 1 or 2 other treatments for HER2 positive breast cancer (1 of which included Herceptin) and your cancer has got worse since your last treatment
- Have at least one area of cancer that is bigger than 2cm across and is measurable on a scan
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are willing to use a reliable form of contraception during the trial and for 4 weeks afterwards if there is any chance you could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have cancer that has spread to your brain or spinal cord, and is growing, causing symptoms, or requires treatment to control symptoms
- Have already had more than 2 types of treatment that target HER2 (your doctor can advise you about this)
- Have had radiotherapy in the last 4 weeks (in the last 2 weeks if it was radiotherapy to control symptoms)
- Have had hormone therapy or chemotherapy in the last 4 weeks (6 weeks if you had mitomycin or 1 of a group of drugs called
- Have had a monoclonal antibody (apart from Herceptin) or another experimental drug in the last 4 weeks
- Have already had a drug that blocks proteins called HSP90 or HDAC (you can check this with your doctor)
- Have diarrhoea that cannot be controlled, or have not recovered from other side effects of earlier cancer treatment (apart from hair loss), unless they are very mild
- Have had any other type of cancer that is now causing symptoms or needs treating
- Have liver or kidney disease
- Have a heart problem that is a cause for concern, or any other medical condition that the trial doctors think could affect you taking part in this trial
- Are taking a drug called warfarin to thin the blood
- Are known to be sensitive to either of the trial drugs
- Are known to be HIV positive
- Are pregnant or breastfeeding
This is an international trial. It will recruit about 52 women from around the world. All the women taking part will have AUY922 and Herceptin.
There are 2 parts to the trial. In part 1, doctors are looking for the highest dose of AUY922 they can give safely at the same time as Herceptin. The first patients taking part will have a low dose of AUY922. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until the researchers find the highest safe dose. This is called a ‘dose escalation study’.
In part 2, the researchers want to learn more about how well the 2 drugs work. People joining the 2nd part of the trial will have the highest safe dose found in part 1.
Every week you have Herceptin, followed by AUY922 through a drip into a vein. This takes about an hour and a half each time. As long as it does not cause bad side effects, you can carry on having the treatment for as long as it helps you.
The trial team will take a number of extra blood samples during the first few weeks of treatment. They use these to look at what happens to the drug in the body. This is called
The researchers will use your tumour sample and a number of blood samples they take during the trial to look for biomarkers. These are substances that doctors can measure to help them tell how a disease is developing or how a treatment is working. If you join the 2nd part of the trial, the researchers may ask you to have extra biopsies before you start treatment and after a few weeks of treatment.
You will see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination including an eye test
- Blood and urine tests
- Chest X-ray
- Heart trace (
- Heart ultrasound (
echocardiogram) or MUGA scan
- Bone scan
- CT scan or MRI scan
A biopsy(if there is not a tissue sample available from when you had surgery)
You go to hospital each week to have the trial treatment, but there are some extra hospital visits during the first few weeks of treatment. You have blood tests and ECGs at most visits. You have a CT or MRI scan
- Every 8 weeks during the first 24 weeks of treatment
- Then every 12 weeks until your cancer starts getting worse or you start another type of treatment
When you finish the trial treatment, you go back to see the doctors 4 weeks later. You will then see them every 3 months until 2 years after the last person has joined the trial. If you have side effects from the treatment, the trial team will see you more often until the side effects get better.
If the treatment is helping you, but you stop having it because of bad side effects, the researchers will ask you to have a CT scan every 3 months until your cancer starts getting worse or you start another treatment. This follow up lasts for up to 2 years.
AUY922 is a new treatment and there may be side effects we don’t know about yet. But the most common side effects people have had so far include
- Skin irritation where you have the drip
- Feeling or being sick
- Bleeding from the back passage
- A drop in the number of red blood cells causing tiredness and breathlessness
- Changes to the rhythm of your heart
- Changes to the way your adrenal glands work – this can be treated with other medication
There is information about the side effects of Herceptin on CancerHelp UK. It is possible that having both drugs together may cause other side effects.
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.
Dr Karla Martins
Experimental Cancer Medicine Centre (ECMC)