“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 veliparib with paclitaxel and carboplatin for breast cancer
This trial is looking at a new drug called veliparib with the chemotherapy drugs paclitaxel and carboplatin for breast cancer. The trial is for people with breast cancer that has spread into surrounding tissue (locally advanced), or to another part of their body (secondary breast cancer). To take part in the trial, your breast cancer must have a change in the
More about this trial
Doctors can treat breast cancer with chemotherapy. Paclitaxel is a chemotherapy drug that doctors use to treat secondary breast cancer. Carboplatin is another chemotherapy drug. Doctors can use the combination of paclitaxel and carboplatin to treat breast cancer.
Veliparib is a cancer drug called a PARP inhibitor. It blocks an
The cells in your cancer already have problems repairing cell damage because of the change in a BRCA gene. Doctors hope that if they can also stop PARP working, the cancer cells will not be able to repair themselves and will die.
In this trial most of the people will have veliparib with paclitaxel and carboplatin. The others will have a dummy drug (
The researchers want to find out how well veliparib works in combination with paclitaxel and carboplatin for breast cancer.
Who can enter
You may be able to join this trial if all of the following apply
- You have breast cancer that has spread into the surrounding tissue and cannot be treated with surgery or radiotherapy with the aim of curing it, or your cancer has spread to another part of your body
- You have breast cancer that has low levels of HER2 receptors (is
- Your cancer has an inherited gene fault (
mutation) in BRCA1or BRCA2(the trial team will test for this)
- You have cancer that can be seen on a scan with at least 1 area that hasn’t been previously treated with
- You have satisfactory blood test results
- 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 tablets
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you, or your partner, could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply
- You have cancer spread to your brain unless it has been treated, you haven’t had symptoms for the last 4 weeks and don’t need to take steroids
- You have had more than 2 other types of chemotherapy for your cancer
- Your cancer continued to grow or came back within a year of having a
platinum chemotherapy drug
- You have had a drug that works in a similar way to veliparib (the trial team can advise you about this)
- You have had
chemotherapyor biological therapyin the last 3 weeks
- You have had radiotherapy in the last 4 weeks before being put into your treatment group for this trial
- You have had major surgery in the last 3 weeks before being put into your treatment group for this trial
- You still have side effects from any cancer treatment unless they are only mild
- You have had another cancer in the past 3 years apart from an
early stage cancerthat has been successfully treated (the trial team can advise you about this)
- You have fits (seizures) that aren’t controlled by medication
- You have an infection
- You have certain heart problems (the trial team can advise about this)
- You have hepatitis B or hepatitis C
- You have high blood pressure that isn’t controlled with medication
- You have any other medical condition or mental health problem that the trial team thinks could affect you taking part
- You are allergic to any drugs that are used in this trial or to anything they contain
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need about 270 people worldwide to join.
It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- People in group 1 have carboplatin, paclitaxel and veliparib
- People in group 2 have carboplatin, paclitaxel and a dummy drug (placebo)
Out of every 3 people joining the trial, 2 will have veliparib and 1 will have the dummy drug.
Veliparib and the dummy drug are capsules. You take them twice a day for a week, and then don’t take them for the next 2 weeks.
You have paclitaxel and carboplatin as a drip into a vein. You have paclitaxel once a week. You have carboplatin once every 3 weeks.
You continue your treatment as long as the side effects aren’t too bad and it is helping you.
If your doctor decides you should stop taking the carboplatin and paclitaxel, you may continue taking the veliparib, or placebo, twice a day every day.
If you agree to take part in this trial, the researchers will ask for a sample of your cancer that was removed when you had surgery or a
They will also ask for some extra blood samples to find out what happens to veliparib in the body.
The trial team will ask you to fill out a questionnaire before you start treatment, every 6 weeks during 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.
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Urine test
- CT scan or MRI scan
- Bone scan
- Testing for
BRCA 1or BRCA 2
During treatment you see the doctor and have a blood test every week. You have another heart trace before starting treatment. You have a CT scan or MRI scan every 9 weeks until you complete the trial.
People whose tumour gets worse during treatment and who had the dummy drug (placebo) may be able to start taking veliparib. The trial doctor will talk to you about this if this happens to you.
At the end of the trial you see the doctor for the same tests you had before you started treatment. A month after completing the trial, you see the doctor for a physical examination and blood tests. You will then go to the clinic, or the trial team will contact you, every 2 months to see how you are.
The most common side effects of veliparib are
- Feeling or being sick
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Diarrhoea or constipation
- Increased levels of sugar in your blood
- Loss of appetite
- Changes to the way your liver works
- Stomach pain
- Problems sleeping
- Decreased levels of magnesium and sodium in your blood
- Taste changes
- Feeling dizzy
We have information about the side effects of
The trial team will talk to you about the possible side effects before you agree to take part.
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 Stephen Chan