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A randomised three-arm multi-centre comparison of 1 year and 2-years of trastuzumab (Herceptin®) versus no trastuzumab in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy.

Disease site: Breast cancer

Treatment modality: Chemotherapy

Status: In active follow-up

Trial details

The primary aim of the study is to compare disease-free survival (DFS) in patients with HER2 over expressing primary breast cancer randomised to Herceptin for 1 year or no further therapy or to Herceptin for 2 years or no further therapy. 

The trial recruited 5,102 women with primary breast cancer that overexpresses HER2 (determined by IHC 3+ or FISH positive). Following the positive results at the interim analysis, all HERA patients on the observation arm have been offered the chance of receiving Herceptin treatment either for 1 year by direct assignment or by randomisation to either 1 or 2 years treatment, or they can choose to remain on the observation arm.

This is an international study run under the auspices of the Breast International Group (BIG).

There are five collaborative groups within the UK which participate in the study:

  • National Cancer Research Institute Breast Clinical Studies Group (NCRI BCSG)
  • Anglo Celtic Cooperative Oncology Group (ACCOG)
  • Yorkshire Breast Cancer Research Group (YBCRG)
  • European Organisation for Research and Treatment of Cancer (EORTC)
  • International Collaborative Cancer Group (ICCG)

UK Chief Investigator: Professor I. E. Smith, Royal Marsden Hospital, Sutton

ISRCTN: 82811952

Sponsor: Roche

Funding: Roche

Further information

More information about the trial can be found on Roche's HERA webpage or see the BIG HERA webpage for a list of publications arising from the research.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.