A trial looking at crizotinib for breast and stomach cancer (ROLo)
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 for people with advanced breast or stomach cancer. This means that the cancer:
- has come back in the same place after treatment (local recurrence)
- has spread to other parts of the body (metastatic)
It is for people who have had at least 1 type of treatment for advanced cancer.
To take part with breast cancer, you must have cells that are sensitive to the hormone oestrogen (oestrogen receptor positive or ER positive). And must not have receptors for a protein called HER2 (HER2 negative).
People with stomach cancer must have a rare type called diffuse stomach cancer (also known as signet cell cancer).
Everyone taking part must be E-cadherin negative. Your doctor can tell you more about this.
More about this trial
Targeted drugs are common treatments for people with advanced breast or stomach cancer. There are many different types of targeted drugs. Some target a particular part of the cancer cell, others help the immune system to kill cancer cells.
Crizotinib (Xalkori) is a type of targeted drug called a cancer growth blocker. It works by blocking certain chemical messengers that tell cancer cells to grow. This stops or slows down the growth of the cancer. Crizotinib is already a possible treatment for some people with advanced lung cancer.
Everyone taking part in this trial takes crizotinib for as long as it helps them, and the side effects aren’t too bad. People with advanced breast cancer, also have fulvestrant injections.
Fulvestrant (Faslodex) is a type of hormone treatment. It works by stopping oestrogen from stimulating breast cancer cells to grow. Fulvestrant is already a treatment for oestrogen receptor positive breast cancer.
The main aim of this trial is to find out how well crizotinib works for people with advanced breast and stomach cancer.
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply:
- you have a rare type of cancer called diffuse stomach cancer or you have
ER positive 
and HER2 negative breast cancer (E-cadherin negative). - your cancer has come back or spread to other parts of the body (advanced)
- you have had at least 1 type of treatment but no more than 3 types of treatment for advanced cancer
- you have 1 area of cancer that can be seen and measured on a scan
- you have satisfactory blood tests results
- your heart is working well
- you are willing to have goserelin (Zoladex) injections every month if you have breast cancer and have periods with no symptoms of menopause (premenopause) or have menopause symptoms but still have periods (perimenopause)
- you can swallow and absorb tablets
- you are up and about more than half the day, you can look after yourself but can’t work (performance status of 0, 1 or 2)
- you are willing to use reliable contraception during treatment and for up to 90 days after the last dose of crizotinib if there is any possibility that you or your partner could become pregnant. You need to use reliable contraception for up to 6 months if you have fulvestrant
- you are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply:
- you have had chemotherapy or an investigational drug in the last month
- you have had hormone therapy in the past week unless it was treatment to stop your ovaries from making oestrogen such as goserelin
- you have had crizotinib or any other similar drug
- you have had radiotherapy in the past 2 weeks
- you have cancer spread in your brain that is causing symptoms and you need to take steroids
- you have cancer in the spine or near the spine that is pressing on the spinal cord and nerves (spinal cord compression)
- you have moderate or severe side effects from previous cancer treatment unless it is hair loss or numbness and tingling in fingers and toes
- you have had another cancer in the last 5 years apart from basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix and breast that have been successfully treated
Medical conditions
You cannot join this trial if any of these apply. You:
- are taking part in another clinical trial looking at a new drug or device
- have had a major surgery in the last month
- have heart problems such as uncontrolled
angina , high blood pressure that isn’t stable or you have had a heart attack in the last year - have problems with your
digestive system and have a high risk of developing a hole in your stomach or bowel - have a severe problem with your kidneys and you are having dialysis
- have had a stroke
- take drugs that affect the CYP enzymes. Your doctor can tell you more about this
- take medicines to thin your blood such as warfarin
- have HIV
- have an active infection
- have any other severe medical condition or mental health problem that doctors think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are pregnant or breastfeeding
- are sensitive to crizotinib or anything it contains
Trial design
This is a phase 2 trial. Researchers hope that around 29 people with breast cancer and 29 people with stomach cancer will agree to take part.
Everyone taking part takes crizotinib as tablets that you swallow whole twice a day. You take them for as long as they are helping you and the side effects aren’t too bad.
People with breast cancer also have fulvestrant. You have it as an injection into the muscle in your buttocks (intramuscular). You have fulvestrant:
- on the first day of crizotinib
- then after 2 weeks
- then every 4 weeks for as long as you take crizotinib
Samples for research
You have extra blood tests as part of this trial. Researchers want to look for certain that can help to tell how well the treatment is working.
Where possible you have them at the same time as your routine blood samples.
The trial team asks to use a tissue sample of your cancer taken when you had a or surgery. You need to have a new sample taken if there isn’t a suitable sample available.
Doctors may also ask you to have a biopsy:
- 2 weeks after you start treatment
- when you finish treatment
You don’t have to agree to the extra biopsies if you don’t want to. You can still take part in this trial.
Hospital visits
You see a doctor and have some tests before taking part. These tests include:
You see the trial team every week, for 2 months. You see the team once a month after that. You have blood tests and a check up each time.
You have a CT scan or MRI scan every 8 weeks for up to 6 months. You then have a CT scan or MRI scan every 3 months. This continues for as long as the treatment is helping you and the side effects aren’t too bad.
When you finish treatment, you see the trial team and have blood tests. You then see or speak with the trial team every 6 months.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of crizotinib are:
- tiredness (fatigue)
- feeling or being sick
- diarrhoea or constipation
- loss of appetite and taste changes
- tummy (abdominal) pain
- changes to your eyesight and dizziness
- swollen ankles
- decreased heart rate
- a drop in the levels of red blood cells causing breathlessness and looking pale
- skin rash
- tingling or numbness in fingers and toes
- changes in the levels of liver enzymes
We have more information about the:
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
Dr Alicia Okines
Supported by
The Royal Marsden NHS Foundation Trust
Cancer Research UK trial number
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
