BIG Breast International Group
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BIG 1-01 HERA (HERceptin Adjuvant) is a randomised three-arm multi-centre comparison of one year and two years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed (neo)adjuvant chemotherapy.

The study results demonstrated that one year treatment with trastuzumab after adjuvant chemotherapy significantly improves disease-free survival among women with HER2-positive breast cancer (NEJM 2005), and OS (Lancet 2007). This benefit is maintained at a longer follow-up (Lancet Oncol 2011 and Lancet 2013).

WHY In HER2-positive breast cancer, increased quantities of a protein known as HER2 that promotes cell growth are present on the surface of the tumour cells. This represents approximately 15-20% of patients with breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease that previously meant poor survival rates.
BENEFITS ACHIEVED The HERA trial contributed to setting a new standard of treatment for patients with early stage HER2-positive breast cancer. HERA helped accelerate the approval of a drug called trastuzumab (Herceptin®) that has decreased relapse rates by 50% and is now the standard treatment for this aggressive cancer type. To date, more than 1.2 million people worldwide have been treated with trastuzumab.
WHAT Trastuzumab is an antibody designed to target and block the function of the HER2 protein. The way the drug works is unique in that it activates the body’s immune system and suppresses HER2 signalling to target and destroy the tumour. Results of the HERA trial indicated that one year of treatment with trastuzumab had a significant and sustained benefit in preventing cancer recurrence and improving overall survival among patients with HER2-positive breast cancer. Two years of the drug was not found to have a significant benefit in comparison to one year of treatment.

WHO Patients

Women diagnosed with early-stage HER2-positive breast cancer who had already received chemotherapy before or after their breast cancer surgery and radiotherapy (if applicable).

Overall recruitment (completed): 5.102 patients
WHO The trial was conducted by the BrEAST European Adjuvant Study Team and Frontier Science Scotland under the Breast International Group (BIG) umbrella; the pharmaceutical industry partner and sponsor was Roche.

The trial compared two different durations of adjuvant (post-surgery) trastuzumab treatment versus the standard of care for enrolled patients:

• Observation (standard of care when the study started)
• One year of trastuzumab
• Two years of trastuzumab

Patients were followed up over a period of 8 years to monitor cancer recurrence and overall survival, and will continue to be followed until 10 years after last patient inclusion. When the first results were made public in 2005, patients on the observation arm were given the option to switch to treatment with trastuzumab.

WHEN Recruitment of 5.102 patients occurred from December 2001 to June 2005.
• The primary results on disease-free survival were reported in 2005, enabling accelerated approval of the drug as standard treatment.
The latest overall survival results were reported in 2012. A final report at 10 years of median follow-up is expected by the end of 2015
• The main results have been published in prestigious journals such as the New England Journal of Medicine and the Lancet. Exploratory analyses continue.

WHERE 480 hospitals in 39 countries participated in this trial through 27 BIG member groups.
 The study was funded by Roche. Identifier: NCT00045032


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