A trial of everolimus with trastuzumab and vinorelbine for advanced HER2 positive breast cancer (BOLERO 3)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial looked at a drug called everolimus alongside trastuzumab (Herceptin) and chemotherapy for breast cancer that has spread to another part of the body. The trial was for women with breast cancer that has large amounts of the protein HER2 Open a glossary item (HER2 positive).

Doctors can use a drug called trastuzumab (Herceptin) to treat HER2 positive secondary breast cancer Open a glossary item. But sometimes a drug can stop working, even though the cancer responded to it at first. Doctors call this resistance Open a glossary item. If you become resistant to trastuzumab your doctors may suggest you try having it with a different chemotherapy drug.

Everyone taking part in this trial had trastuzumab alongside a chemotherapy drug called vinorelbine. Some people also had a drug called everolimus.

Everolimus is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The aims of this trial were to find out

  • If having everolimus alongside trastuzumab (Herceptin) and vinorelbine helps women with HER2 positive breast cancer that has spread to another part of the body
  • More about the side effects

Summary of results

The trial team found that having everolimus alongside trastuzumab and vinorelbine helped women with HER2 positive secondary breast cancer.

569 women who had become resistant to trastuzumab (Herceptin) and who had already had treatment with a taxane drug Open a glossary item took part. Of those

  • 284 women had trastuzumab, vinorelbine and everolimus
  • 285 women had trastuzumab, vinorelbine and a dummy drug (placebo)

The trial team looked at the average length of time women lived without signs of their cancer getting worse. They found this was

  • 7 months in the group who had everolimus
  • Just under 6 months in the group who had the dummy drug

More women in the everolimus group had problems with a sore mouth, tiredness (fatigue) and a drop in red and white blood cells causing an increased risk of infections and tiredness.

The trial team concluded that the combination of everolimus, trastuzumab and vinorelbine extended the length of time before the cancer started to grow again in this group of women but it caused more side effects.

We have based this summary on information from the team who ran the trial. 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. We have not analysed the data ourselves.

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 Perren

Supported by

Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Novartis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

4157

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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