A trial looking at crizotinib for breast and stomach cancer (ROLo)

Cancer type:

Breast cancer
Secondary cancers
Stomach cancer

Status:

Open

Phase:

Phase 2

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 diffused stomach cancer or you have ER positive Open a glossary itemand HER2 negative Open a glossary item  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 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 2 months 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 Open a glossary item 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 Open a glossary item, high blood pressure that isn’t stable or you have had a heart attack in the last year
  • have problems with your digestive system Open a glossary item and have a high risk of developing a hole in your stomach or bowel
  • 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  

Blood tests

You have extra blood tests as part of this trial. Researchers want to look for certain genes Open a glossary item that can help to tell how well the treatment is working.

You have the extra blood tests before the start of treatment and when you finish treatment.

Tissue sample

The trial team asks to use a tissue sample of your cancer taken when you had a biopsy Open a glossary item 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 have blood tests, a physical examination and a heart trace each time you see them. You then see the trial team every 4 weeks.

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:

We have more information about the side effects of crizotinib. And information about the side effects of fulvestrant.

Location

London

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 Alicia Okines

Supported by

The Royal Marsden NHS Foundation Trust

Cancer Research UK trial number

16382

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16382

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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