A trial of veliparib with paclitaxel and carboplatin for breast cancer (Brocade 3)

Cancer type:

Breast cancer

Secondary cancers

Status:

Results

Phase:

Phase 3

This trial looked at adding a drug called veliparib to chemotherapy for breast cancer.

It was for people with breast cancer with all of the following. The cancer:

had spread into tissue surrounding the breast or to another part of the body
had the BRCA1 or BRCA2 gene change (mutation)
was HER2 negative

This trial was open for people to join between 2014 and 2017. The team published the results in 2020.

More about this trial

Some breast cancers have either none or very little HER2. They are called HER2 negative cancers. Doctors can use chemotherapy to treat HER2 negative breast cancer. One of the chemotherapy drugs they use is called paclitaxel. Carboplatin is another chemotherapy drug.

When this trial was carried out, doctors used the combination of paclitaxel and carboplatin to treat advanced breast cancer. In this trial they looked at adding a drug called veliparib. Researchers thought it might improve treatment. But they weren’t sure so wanted to find out more.

Veliparib is a cancer drug called a PARP inhibitor Open a glossary item . It blocks an enzyme called PARP. This helps damaged cells repair themselves.

Cancer cells with BRCA gene faults already have a poor repair system. So blocking PARP with a PARP inhibitor drug means that the cells are not able to repair themselves and they die.

In this trial most people taking part had veliparib and chemotherapy. The rest had chemotherapy and a dummy drug (placebo Open a glossary item ).

The main aims of the trial were to:

find out if adding veliparib to chemotherapy improves treatment
learn more about the side effects

Summary of results

The trial team found that adding veliparib to chemotherapy worked for people with breast cancer that had spread. It increased the length of time before the cancer started to grow again. The team also say that adding veliparib didn’t make the side effects much worse.

About this trial
This was a phase 3 trial. There were 2 treatment groups. The people taking part were put into a treatment group at random. Two out of every 3 people had veliparib and chemotherapy. And 1 out of every 3 people had chemotherapy and a dummy drug.

509 people joined the trial and:

337 had chemotherapy and veliparib
172 had chemotherapy and a dummy drug

brocade_3.png

Neither the people taking part nor their doctor could choose which group they were in. Nor did they know which group they were in. This is a double blind trial. People could continue with veliparib or the dummy drug on its own if the cancer got worse.

Results
The researchers looked at how long before the cancer started to grow again. They looked at the average number of months it took. They found this was:

12.6 months for people who had chemotherapy and the dummy drug
14.5 months for people who had chemotherapy and veliparib

brocade_3_1.png

At 2 years they looked at the number of people living whose cancer hadn’t started to grow again. This was:

81 people who had chemotherapy and a dummy drug
23 people who had chemotherapy and veliparib

At 3 years they looked at the number of people living whose cancer hadn’t started to grow again. This was:

32 people who had chemotherapy and a dummy drug
8 people who had chemotherapy and veliparib

The team looked at how long people lived. They didn’t find a difference in how long people lived between the 2 treatment groups. But they say they haven’t done the final analysis yet. This is because researchers are still following up some people who took part. We plan to update this when the results are available. The team say this might be at the end of 2022.

Side effects
The more common side effects of all treatment included:

a drop in blood cells causing an increased risk of infection, bruising or bleeding, tiredness and breathlessness
feeling or being sick

People who had veliparib had more problems with:

a drop in red blood cells causing an increased risk of tiredness or breathlessness
a drop in platelets causing an increased risk of bruising or bleeding
feeling or being sick

When side effects are too severe or too many, the trial team might decide to reduce the dose of the drug. In this trial, a similar number of people had their:

chemotherapy dose reduced
veliparib or dummy drug dose reduced

Quality of life
The team looked at how people rated their quality of life Open a glossary item . The team didn’t find a difference between the 2 treatment groups.

Conclusion
The trial team concluded that adding veliparib to chemotherapy worked for people with advanced breast cancer. It increased the length of time before the cancer started to grow again compared to the dummy drug.

The team think that veliparib, with carboplatin and paclitaxel should be a possible treatment option for people with advanced breast cancer. This group includes people who have the BRCA gene change and are suitable to have chemotherapy.

Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.