A trial looking at a vaccine for breast cancer with HER2 (PRESENT)

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

Cancer type:

Breast cancer




Phase 3

This trial is looking at a new vaccine called Neuvax for breast cancer that has receptors for the HER2 protein and has spread to the lymph nodes.

Doctors may test your breast cancer cells to see if they have a receptor for a protein called HER2. Breast cancers that have a large number of these receptors are called HER2 positive. Doctors can treat HER2 positive breast cancer with a biological therapy called trastuzumab (Herceptin). But trastuzumab doesn’t work well for breast cancer that has low to moderate amounts of the HER2 receptor.

Neuvax is a vaccine. It combines a man made protein that is similar to the HER2 protein with a drug called GM-CSF Open a glossary item. Doctors can use GM-CSF to stimulate the body’s immune system. The researchers hope that Neuvax will stimulate the immune system to attack any remaining breast cancer cells in the body that have the HER2 protein after completing standard of care therapy. In this trial some people will have Neuvax and some people will have GM-CSF. The researchers will compare the 2 groups.

The aims of this trial are to find out

  • How well Neuvax works for breast cancer that has spread to the lymph nodes and has low to moderate amounts of HER2 protein
  • How safe Neuvax is

Who can enter

You may be able to enter this trial if you are a woman and

You cannot enter this trial if

  • You have had breast cancer before
  • You have cancer in both breasts
  • You have cancer that has spread into your chest wall or skin
  • You have inflammatory breast cancer
  • Your cancer had spread to the lymph nodes of your armpit and the lymph nodes were stuck to each other – your doctor can confirm this
  • Your cancer had spread to the lymph nodes behind your breast bone or around your collar bone – your doctor can confirm this
  • You had a type of breast cancer called DCIS (ductal carcinoma in situ) previously
  • You have had trastuzumab (Herceptin)
  • You have had another cancer in the past 5 years apart from superficial bladder cancer, carcinoma in situ of the cervix and non melanoma skin cancer
  • You still have moderate to severe side effects from your treatment – your doctor can confirm this
  • You have a serious heart problem
  • You have an autoimmune disease Open a glossary item or another problem with your immune system Open a glossary item
  • You are taking steroids, apart from creams, or other medication that affects how your immune system works – your doctor will know what is acceptable
  • You are taking an experimental drug as part of another clinical trial
  • You are allergic to Neuvax or any of its ingredients
  • You are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. It will recruit at least 700 women 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 either. This is called a double blind trial.

You will be put into 1 of 2 groups

  • Those who have Neuvax
  • Those who have GM-CSF

PRESENT trial diagram

You have Neuvax or GM-CSF as an injection under the skin. You have it every 4 weeks for 6 months and then every 6 months for 3 years.

Hospital visits

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

During treatment you see the doctor for a physical examination and blood tests every month for 7 months, at 9 months and 1 year, and then every 3 months until you finish the trial treatment. You have a heart scan at 3 months, 6 months, 1 year and then every 3 months. You have a heart trace, CT scan or MRI scan, chest X-ray, mammogram, bone scan and urine test every year.

After you finish treatment, you see the doctor every 3 months for another 2 years and then every 6 months for a further 5 years.

Side effects

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

  • Fever and chills
  • Redness and pain at the injection site
  • Bone pain
  • Flu like symptoms
  • Tiredness
  • Headache
  • Sore, painful muscles
  • Difficulty breathing and wheezing
  • A drop in blood pressure causing dizziness or feeling light headed
  • Swelling around the mouth, eyes and of the throat
  • A fast pulse
  • Sweating

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 Mary O'Brien

Supported by

Experimental Cancer Medicine Centre (ECMC)
Galena Biopharma
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10450

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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