A trial of niraparib for breast cancer with a change to the BRCA gene and is HER2 negative (BRAVO)

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This trial is looking at a new drug called niraparib for breast cancer. It is for women who have previously had treatment for breast cancer that has spread into the surrounding tissue or to another part of the body. To enter the trial, your breast cancer must also have a change in the BRCA gene and a small number of HER2 receptors (HER2 negative).

Doctors can treat breast cancer that has spread with chemotherapy drugs. The cancer may get smaller or completely disappear. But it can start growing again later on. Researchers are looking for new treatments to help stop breast cancer coming back after you’ve had chemotherapy. In this trial, they are looking a drug called niraparib.

Niraparib is a type of biological therapy called a PARP inhibitor. This means it blocks an enzyme called PARP, which helps damaged cells to repair themselves.

The cells in your cancer already have problems repairing cell damage, because of the BRCA gene fault. Doctors hope that if they can also stop PARP working, the cancer cells will not be able to repair themselves and will die.

The people taking part in this trial have had chemotherapy at least twice and their cancer responded well each time. The aim of the study is to see if taking niraparib helps people in this situation, and whether it delays the cancer coming back again.

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 (locally advanced) or to another part of your body and cannot be removed with surgery or treated with radiotherapy with the aim of curing it
  • You have a change to the gene called BRCA1 or BRCA2 (if your doctor does not know whether you have a change to either of these genes, you will have a test to check this as part of the trial screening process)
  • Your cancer has a small number of HER2 receptors (HER2 negative)
  • Your cancer has continued to get worse in the past 3 months
  • You have an area of cancer that can be measured on a scan
  • You have had no more than 2 previous courses of chemotherapy for your cancer spread. If you haven’t had chemotherapy to treat your cancer spread yet, you may join if your cancer came back or got worse during your initial treatment for early breast cancer, or within a year after that treatment
  • You have had previous treatment with a taxane chemotherapy drug, an anthracycline chemotherapy drug or both. If your cancer has hormone receptors it must have continued to get worse during hormone treatment
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are able to swallow tablets
  • You are willing to use 2 reliable forms of contraception during treatment and for 3 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 that has spread to your brain and is causing symptoms
  • Have had any other anti cancer treatment in the 3 weeks before you agree to take part in this trial
  • Have had a platinum chemotherapy drug to treat your cancer spread. You may be able to take part if your cancer got worse 8 weeks, or more, after your last dose of the drug
  • Have had a platinum chemotherapy drug as your first treatment to shrink the cancer before your surgery or radiotherapy. You may be able to take part if your cancer got worse at least a year after your last dose of the drug
  • Still have side effects from any previous treatment, apart from hair loss
  • Have already had niraparib or a similar drug, apart from iniparib
  • Are known to be sensitive to niraparib, or similar drugs, and their ingredients
  • Have had a transfusion of platelets within 4 weeks of having your first dose of treatment in this trial
  • Have had major surgery in the past 2 weeks or haven’t recovered from any previous major surgery
  • Have had another cancer in the past 2 years apart from non melanoma skin cancer that has been successfully treated
  • Have a problem with your immune system
  • Have tested positive for HIV, hepatitis B or hepatitis C
  • Have certain heart problems (the trial team can tell you more about this)
  • Have any other medical or mental condition that could affect you taking part in this trial
  • Are pregnant or breastfeeding

Trial design

This is a phase 3 trial. The researchers need 324 people to join.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • 2 out of every 3 people will have niraparib
  • 1 out of every 3 people will have their doctor’s choice of chemotherapy treatment

11991 Trial Diagram

Niraparib is a capsule. You take 3 capsules every morning with a glass of water. Your doctor will tell you if your dose needs to change.

For the people in the 2nd group, your doctor can choose to give you one of the following chemotherapy drugs

You have eribulin and gemcitabine into a vein. You can have vinorelbine into a vein or as a capsule. You have capecitabine as a tablet. Your doctor will talk to you about how you have your treatment.

You continue treatment as long as it is helping you and the side effects aren’t too bad.

The trial team will ask you to fill out a questionnaire before you start treatment, every 6 weeks for a year, then every 3 months while you are still having 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.

The trial team will ask people having niraparib for a few extra blood tests. They will use these samples to find out more about what happens to niraparib in the body.

When you joined the trial if your cancer was tested and it doesn't have a change in the BRCA genes, you may still be able to coninue taking part. Your trial doctor can advise you about this.

Hospital visits

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

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG)
  • CT scan or MRI scan

During treatment you see the doctor every 3 weeks for a physical examination and blood tests. You have another heart trace after 6 weeks. You have a CT scan or MRI scan every 6 weeks for a year and then every 3 months until your cancer starts to grow again.

You see the doctor a month after stopping treatment and then every 3 months until your cancer starts to grow again or you start another anti cancer treatment.

Side effects

Niraparib is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include

Niraparib may also make your skin more sensitive to ultraviolet light. So you must take care to limit your exposure to the sun and other forms of ultraviolet light.

Your doctor will talk to you about the possible side effects before you agree to take part.

We have information about the side effects of

Location

Cardiff
Edinburgh
Glasgow
London
Northwood
Nottingham
Surrey

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 Nick Turner
Dr David Cameron

Supported by

Breast International Group (BIG)
European Organisation for Research and Treatment of Cancer (EORTC)
TESARO

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11991

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

Harriet wanted to try new treatments

Picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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