A trial of lucitanib for breast cancer that has spread (FINESSE)
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 a new drug called lucitanib to treat breast cancer. The trial is for women with breast cancer that has spread to another part of their body and is sensitive to the female hormone oestrogen (
or ER positive).
More about this trial
Doctors can use biological therapies to treat breast cancer that has spread to another part of the body. Lucitanib is a biological therapy. It works by blocking the growth of blood vessels to the cancer.
Researchers think it may also work by stopping the signals that cancer cells use to divide and grow. But only for cancer cells that have too many copies of certain . To find this out they will take a small piece of tissue (a ) from your cancer and look for extra copies of these genes.
The main aim of this trial is to find out how well lucitanib works for breast cancer that has too many copies of certain genes. The researchers also want to find out more about the side effects of lucitanib.
Who can enter
You may be able to join this trial if you are a woman and all of the following apply
- You have a type of breast cancer called adenocarcinoma that has spread to another part of your body
- Your cancer is sensitive to the female hormone oestrogen (
oestrogen receptor positive or ER positive) - You have already had 1 type of anti cancer treatment, apart from radiotherapy for cancer that has spread
- Your cancer continued to grow during treatment or came back afterwards
- You have at least 1 area of cancer that can be seen and measured on a scan
- Your heart works well enough (your doctor will test for you for this)
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are able to swallow capsules
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have breast cancer that has a large number of HER2 receptors (is
HER2 positive ) - Have cancer that has spread to your brain or spinal cord and is causing symptoms. You may be able to take part if your cancer spread hasn’t caused symptoms in the last month and you aren’t taking a high dose of steroids
- Have had more than 2 other types of chemotherapy to treat your cancer spread
- Have had bevacizumab (Avastin) in the last 3 months
- Have taken part in another clinical trial in the last month
- Are taking certain medications that could affect you taking part (the trial team can advise you about this)
- Have certain heart or kidney problems (the trial team can advise you about this)
- Have diabetes that isn’t controlled with medication
- Have high blood pressure that isn’t controlled with medication
- Have a problem with your
thyroid gland that isn’t controlled by medication - Have any other medical condition or mental health problem that the trial team thinks could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The trial team need 123 women to join. Everyone will have lucitanib.
Lucitanib is a capsule you take every day. Your doctor will tell you how many capsules you need to take. As long as the side effects aren’t too bad, you can continue taking lucitanib for as long as it is helping you.
The researchers need a sample of tissue (a ) taken from where your cancer has spread to. If you haven’t already had a biopsy, you must agree to have one to be able to join the trial. They will use the sample to look for certain changes in the of the cancer cells.
They will also ask for another sample of tissue between 2 and 4 weeks after starting treatment and at the end of your treatment. They will use these to look for substances in the tissue () that may show how well lucitanib is working. You don’t have to agree to have these biopsies if you don’t want to. You can still take part in the trial.
The team will also ask for some extra blood samples. They will use these to find out what happens to lucitanib in the body.
Hospital visits
You see the doctor to have some tests before taking part in the trial. These tests include
- A physical examination
- Blood tests
- CT scan or MRI scan
- Heart trace (
ECG ) - Heart scan (
ECHO or MUGA ) - Urine sample
You need to measure and record your blood pressure twice a week before starting treatment. The trial team will give you the equipment to do this and show you how to take your own blood pressure and record it in a diary they give you. During the 1st month of treatment, you take your blood pressure every day. After this the trial doctor will tell you how often you need to take it.
For the 1st month of treatment, you see the doctor every week and have
- A physical examination
- Blood tests
- Heart trace
- A blood pressure check
- Urine test
During the 2nd month of treatment, you see the doctor every week and have a physical examination, blood tests and blood pressure check. After the first 2 months, you see your doctor every 4 weeks. You have a heart trace and a CT or MRI scan every 8 weeks.
When you finish treatment, you see your doctor 4 weeks later and have the same tests you had at the start of the trial. Your doctor will then tell you how often they want to see you.
Side effects
Lucitanib is a new drug and there may be side effects we don’t know about yet. In trials so far, the side effects have included
- An increase or decrease in your blood pressure
- A change to the way your liver, heart and kidneys work
- A change to the way your thyroid gland works causing tiredness, weight gain or sensitivity to the cold
- Loss of muscle strength and weakness
- Tummy (abdominal) pain
- Diarrhoea
- Feeling or being sick
- Loss of appetite
- A drop in the blood cells that help the blood to clot (platelets) causing an increased risk of bruising and bleeding
The trial doctor will talk to you about all the possible side effects before you agree to take part.
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 Nick Turner
Supported by
Breast International Group (BIG)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Servier Research and Development Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
