A trial of veliparib with paclitaxel and carboplatin for breast cancer

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

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 BRCA1 Open a glossary item or BRCA2 Open a glossary item gene and only a small number of HER2 receptors Open a glossary item (HER2 negative).

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 enzyme Open a glossary item called PARP, which helps damaged cells repair themselves.

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 (placebo Open a glossary item) with paclitaxel and carboplatin.

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 HER2 negative Open a glossary item)
  • Your cancer has an inherited gene fault (mutation Open a glossary item) in BRCA1 Open a glossary item or BRCA2 Open a glossary item (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 radiotherapy Open a glossary item
  • 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 Open a glossary item
  • You have had a drug that works in a similar way to veliparib (the trial team can advise you about this)
  • You have had chemotherapy Open a glossary item or biological therapy Open a glossary item in 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 cancer Open a glossary item that 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

Trial design

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 biopsy Open a glossary item. They will use these samples to find out why some people benefit from having veliparib and others don’t. They will also use the samples to find out more about breast cancer. If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

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.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

  • A physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Urine test
  • CT scan or MRI scan
  • Bone scan
  • Testing for BRCA 1 Open a glossary item or BRCA 2 Open a glossary item

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.

Side effects

The most common side effects of veliparib are

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.

Location

Birmingham
Bristol
Hull
Nottingham

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 Stephen Chan

Supported by

AbbVie

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13041

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“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."

Last reviewed:

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