A trial of Herceptin versus no Herceptin for early breast cancer (HERA, BIG 01-01)

Cancer type:

Breast cancer




Phase 3

This trial was looking at Herceptin for breast cancer that has not spread to another part of the body.

Doctors usually treat breast cancer with surgery, and sometimes with radiotherapy, chemotherapy or hormone therapy as well.

Trastuzumab (Herceptin) is a monoclonal antibody. It kills breast cancer cells that make too much of a protein called HER2. Breast cancer makes too much HER2 protein in between 12 and 30 out of every 100 women diagnosed (12 to 30%). Doctors often call this ‘HER2 positive’ breast cancer.

Researchers had tested trastuzumab in clinical trials for patients with advanced breast cancer. The aim of this trial was to see if trastuzumab helped women with HER2 positive early breast cancer.

Summary of results

The researchers found that breast cancer came back less often in the group of women who had trastuzumab.

The trial recruited about 5,100 women who had had surgery, chemotherapy and possibly radiotherapy for HER2 positive early breast cancer.

  • A third of them had trastuzumab every 3 weeks for a year
  • A third had it every 3 weeks for 2 years
  • A third didn’t have trastuzumab

After following the women’s progress for an average of one year, the trial team published some results. These showed that in the group not having trastuzumab, 220 (about 1 in 8) women had

  • A recurrence Open a glossary item of breast cancer
  • Cancer in the other breast
  • Another cancer
  • Or had died

In the group of women having trastuzumab for one year, this had happened to only 127 (about 1 in 13) women.

The most important side effect of trastuzumab was damage to the heart. 9 women having the drug developed severe heart failure. And in 7 out of 100 women (7%) who had trastuzumab, tests showed their heart was not working as well as it had been before the treatment. In the group not having trastuzumab, this happened to just over 2 out of 100 women (2%).

In 2013, the trial team published some long term results. At this point, the women taking part in the study had been followed up for an average of 8 years. They looked at how many of the women who had trastuzumab were living free of cancer in April 2012. Researchers call this disease free survival.

They found there was no significant difference in the number of women who were living free of cancer between the group of women who had trastuzumab for 1 year and those who had it for 2 years. But more women treated with trastuzumab for 2 years had side effects.

The benefit for patients having trastuzumab (1 or 2 years) has been confirmed to be significant Open a glossary item after such a long follow up time.

The researchers concluded that 1 year of trastuzumab should remain standard treatment Open a glossary item for women with HER2 positive early breast cancer.

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

Professor Ian Smith

Supported by

Breast International Group (BIG)
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/01/012.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 34

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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