A trial looking at bevacizumab and paclitaxel for HER2 negative breast cancer that has spread or come back (MERiDiAN)

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Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial looked at bevacizumab with paclitaxel for breast cancer that has come back or spread to another part of the body. It was for people whose breast cancer cells have none or a low amount of a protein called HER2 (HER2 negative cancer).

More about this trial

Doctors sometimes use chemotherapy such as paclitaxel (Taxol) to treat HER2 negative breast cancer that has spread or come back after treatment.

In this trial, they looked at a monoclonal antibody called bevacizumab (Avastin), alongside chemotherapy. Some people had paclitaxel and bevacizumab, and some had paclitaxel and a dummy drug (placebo).

Monoclonal antibodies target particular proteins on cancer cells. Bevacizumab targets a protein called vascular endothelial growth factor (VEGF).

The research team also took blood samples from the people who took part, before they started treatment. They measured the amount of a protein called plasma vascular endothelial growth factor A (pVEGF-A). They hoped there would be a link between the amount of pVEGF-A in the blood samples and how well bevacizumab worked.

The aims of this trial were to find out:

  • how well bevacizumab and paclitaxel works for HER2 negative breast cancer that has come back or spread
  • if bevacizumab works better for people with a high level of pVEGF-A

Summary of results

This trial showed that bevacizumab and paclitaxel worked better than paclitaxel alone for HER2 negative breast cancer that had spread. But that the level of pVEGF-A wasn’t linked to how well treatment worked.

Results
This trial recruited nearly 500 people with none or a low amount of the protein HER2 (HER2 negative breast cancer). They all had cancer that had come back or spread to another part of the body.

The people taking part were put into 1 of 2 groups at random, and:

The research team looked at how long it was before people’s cancer started to grow. They found it was longer for those who had bevacizumab:

  • 11.0 months for those who had paclitaxel and bevacizumab
  • 8.8 months for those who had paclitaxel and the placebo

They then looked at the results in more detail, depending on the level of pVEGF-A in people’s blood samples. About half the people taking part had a high level, and half had a low level.

Again they looked at how long it was before the cancer started to grow. The results showed it was longer for those who had bevacizumab in both the high and low pVEGF-A groups. So measuring the amount of pVEGF-A in the blood before treatment isn’t a useful way of deciding whether people should have bevacizumab or not.

Side effects
People in both groups had side effects, but more people in the bevacizumab group did. Some were mild or short lived, but some were more severe. The most common severe side effects for both groups were a drop in white blood cells and high blood pressure.

There is more information about the side effects of paclitaxel and bevacizumab in our Cancer Drugs section.

Conclusion
The research team concluded that paclitaxel and bevacizumab helped stop HER2 negative breast cancer growing for longer than paclitaxel alone. But they do not support the use of pVEGF-A levels to predict who should have bevacizumab as part of their treatment.

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.

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 David Miles

Supported by

Experimental Cancer Medicine Centre (ECMC)
Hoffmann LaRoche
NIHR Clinical Research Network: Cancer

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Last review date

CRUK internal database number:

10176

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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