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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at bevacizumab (Avastin) with paclitaxel (Taxol) for breast cancer that has come back in the same place or spread to another part of the body. It is for people whose breast cancer cells have low or no amounts of the HER2 protein (HER2 negative).

Doctors can use chemotherapy to treat HER2 negative breast cancer that has spread or come back after treatment. One chemotherapy drug they use is paclitaxel. This works well, but doctors are always looking for ways to improve treatment. In this trial, they are looking at a drug called bevacizumab.

Some people will have bevacizumab and paclitaxel. Some will have a dummy drug (placebo Open a glossary item) and paclitaxel. The researchers will also take blood and tissue samples to look for substances called biomarkers Open a glossary item that can show if bevacizumab is helping.  

The aims of this trial are to find out

  • How well bevacizumab with paclitaxel works for people with breast cancer that has come back or spread
  • Which people treated with paclitaxel may benefit more from having bevacizumab as well

Who can enter

You may be able to enter this trial if

  • Your breast cancer has spread to another part of your body, or has come back in the same place and can’t be removed with surgery
  • Your breast cancer has low or no amounts of the HER2 protein (HER2 negative)
  • You have satisfactory blood test results
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • 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, apart from any containing hormones such as the pill  – your doctor can advise about this
  • You are at least 18 years old

You cannot enter this trial if you

  • Have breast cancer that has a large amount of the HER2 protein (HER2 positive)
  • Have cancer that has spread to your brain or spinal cord unless it has been treated and you aren’t taking steroids
  • Have already had chemotherapy to treat cancer that has come back or spread to another part of your body– if you had chemotherapy for early breast cancer and it was completed at least a year ago you may be able to take part
  • Have had radiotherapy in the past 3 weeks
  • Have had hormone therapy in the past 2 weeks
  • Still have bad side effects from previous radiotherapy
  • Have had an experimental drug as part of another clinical trial in the past month
  • Have severe nerve damage Open a glossary item
  • Have an infection that needs antibiotics through a drip into a vein Open a glossary item
  • Have cancer in both breasts
  • Have had another cancer in the past 5 years apart from a few successfully treated early cancers Open a glossary item
  • Have had very high blood pressure in the past or now have high blood pressure that isn’t controlled with medication
  • Have had a stroke, heart attack or unstable heart pain (angina) in the past 6 months
  • Have any other serious heart problem
  • Have coughed up more than 1½ teaspoons of bright red blood in the past month
  • Have a problem with bleeding – if you bleed easily due to taking blood thinning drugs, such as warfarin you may be able to take part
  • Have had major surgery in the past month or minor surgery in the past 7 days
  • Have had a tear in your bowel or a fistula Open a glossary item in your tummy (abdomen) in the past 6 months
  • Have a wound that isn’t healing, or a recent bone fracture that hasn’t healed
  • Have any other medical condition that could affect you taking part in this trial
  • Have already had bevacizumab or similar drugs – your doctor can confirm this
  • Are allergic to bevacizumab, paclitaxel or their ingredients
  • Are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit 480 people from different countries around the world. 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. And neither of you will know which group you are in. This is called a double blind trial.

Half the people will have bevacizumab and paclitaxel. The other half will have paclitaxel and a dummy drug (placebo).

MERiDiAN trial diagram

You have bevacizumab or the dummy drug as a drip into a vein every 2 weeks. You have paclitaxel as a drip into a vein every week for 3 weeks, followed by a week without treatment.

The first time you have bevacizumab, or the dummy drug, it will take an hour and a half. If you don’t have any problems, you will be able to have it in an hour the next time. If there are still no problems, you can have it in half an hour for all other treatments.

You continue having treatment as long as it is helping you. If you stop treatment due to side effects, you may be able to restart your treatment when you feel better. Your doctor will talk to you about this if it happens.

If you stop having bevacizumab (or the dummy drug) for any reason, you may continue having paclitaxel. If you stop having paclitaxel due to a severe reaction, you may continue having bevacizumab or the dummy drug.  

If you agree to take part in this study, the researchers will ask for extra blood samples and a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. They want to look for substances in the blood (biomarkers Open a glossary item) that may tell them how well the treatment is working.

Hospital visits

You see the doctor and have some tests before taking part in the trial. These tests may include

  • A physical examination
  • Blood tests
  • Urine test
  • Heart trace (ECG Open a glossary item)
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • CT scan or MRI scan

During treatment, you see your doctor 4 times in the first 6 weeks for a physical examination and blood tests. You then see them every 8 weeks for a physical examination, blood tests and a CT or MRI scan.

When you finish treatment, you see the doctor every 3 months for about 3 years.

If you stopped treatment before your cancer started to get worse, you will have a CT or MRI scan every 8 weeks until it does start to get worse.

Side effects

The most common side effects of bevacizumab are

Your doctor will talk to you about the side effects of all the drugs used in this trial before you agree to take part.

We have information on bevacizumab and paclitaxel in our cancer drugs section.

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)
National Institute for Health Research Cancer Research Network (NCRN)
Roche

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10176

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

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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