“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 fulvestrant with AZD2014 or everolimus for advanced breast cancer (MANTA)
This trial is looking at a drug called fulvestrant on its own and alongside either a new drug called AZD2014 or a drug called everolimus. This trial is for people with breast cancer that has come back after treatment or has spread to another part of their body and has receptors for the hormone oestrogen.
Breast cancer that has
In this trial, researchers want to find out if having either everolimus or AZD2014 with fulvestrant improves treatment.
Everolimus is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. Doctors sometimes use everolimus with hormone therapy other than fulvestrant to treat ER positive breast cancer.
AZD2014 is also a type of biological therapy that works in a similar way to everolimus.
The researchers want to compare
- Fulvestrant and AZD2014
- Fulvestrant and everolimus
The main aim of this trial is to find out which works best for ER positive breast cancer that has come back after treatment or has spread to another part of the body.
Who can enter
You may be able to join this trial if you are a woman and all of the following apply
- You have breast cancer that has come back or has spread to another part of your body
- Your cancer has come back after treatment or continued to grow during treatment
- You have at least 1 area of cancer that can be seen on a scan and is at least 10mm in diameter (it must be15mm or more if it is in a lymph node or is an area of cancer spread to a bone)
- Your cancer has a large number of oestrogen hormone receptors (it is ER positive)
- Your cancer has few, or no receptors for
HER2(it is HER2 negative)
- Your cancer continued to grow while having hormone therapy drugs called
aromatase inhibitorsor came back afterwards
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You have satisfactory blood test results
- You have been through the menopause and your periods have stopped (you are post menopausal)
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer spread to your brain or you have cancer spread to another part of your body that is considered to be life threatening
- Have had more than 1 type of chemotherapy treatment for secondary breast cancer
- Have had other cancer treatment within 2 weeks of starting treatment in this trial
- Have had radiotherapy to more than about a third of your
bone marrow(your doctor can tell you about this)
- Have had radiotherapy to the whole of the area between your hips (your pelvis) or to your spine
- Have already had fulvestrant or everolimus
- Have had drugs called PI3K inhibitors, Akt inhibitors or mTOR inhibitors (your doctor can tell you this)
- Are taking medication that damps down your
- Have had treatment with steroids in the past month unless it was a very low dose (creams, inhalers or eye drops are allowed)
- Have problems with your
digestive systemthat could affect how you absorb tablets or capsules
- Have problems with your chest that affects your breathing
- Have certain heart problems (the trial team can advise you about this)
- Take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
- Have had a
growth factorthat encourages your bone marrow to make blood cells (your doctor can tell you this)
- Are sensitive to AZD2014, everolimus, fulvestrant, castor oil or any of their ingredients
- Are having
hormone replacement therapy (HRT), and are unwilling to stop taking it. If you are willing to stop it your last dose must have stopped more than a week before taking part in this trial
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
This is a phase 2 trial. The researchers need 300 people to join.
It is a randomised trial. The people taking part are put into 1 of 4 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in group 1 have fulvestrant only
- People in group 2 have fulvestrant and AZD2014 tablets for 2 days of every week
- People in group 3 have fulvestrant and AZD2014 tablets every day
- People in group 4 have fulvestrant and everolimus tablets every day
You have fulvestrant as 2 injections, one into each buttock. You have it every 2 weeks for the first month and then every 4 weeks afterwards.
AZD2014 is a tablet that you take twice a day. You take it 2 hours before eating or wait an hour after eating before taking it.
Everolimus is a tablet that you take once a day.
You can continue with your treatment as long as it helping you and the side effects aren’t too bad.
If you are having fulvestrant and everolimus, and your cancer gets worse you may be able to change to fulvestrant and AZD2014. Your doctor will talk to you about this.
The trial team will ask you to fill out a questionnaire before you start treatment, every 2 months for 6 months, then every 3 months for the rest of the time you have treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for a sample of your cancer that was removed when you had surgery or a
During the trial, the researchers will also ask for another sample of your cancer. If you don’t want to give this, you don’t have to. You can still take part in the trial.
They will use these samples to find out more about breast cancer.
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Heart scan (
- CT scan
- Bone scan
- Breathing tests (
Lung function tests)
During treatment you see the doctor every 4 weeks for a physical examination and blood tests. You have another heart trace 2 weeks after starting treatment.
When you finish treatment, you see the doctor every 3 months.
AZD2014 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include
- Loss of appetite
- Weight loss
- Feeling or being sick
- Skin rash
- Sore mouth
- Shortness of breath
- A high level of sugar in your blood
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.
Professor Peter Schmid
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Queen Mary University of London