SAN ANTONIO—Trastuzumab after adjuvant chemotherapy for HER2-positive early breast cancer is associated with superior long-term disease-free survival and overall survival rates, compared to observation, reported authors of a final 10-year follow up analysis from the phase 3 international HER (BIG 1-01) clinical trial. The findings were presented at the 2015 San Antonio Breast Cancer Symposium.1

“Results at completion of follow-up show sustained and stable DFS and OS benefit with trastuzumab,” reported lead study author Christian Jackisch, MD, PhD, of the Sana Klinikum Offenbach in Germany. “The standard of care remains 1 year of trastuzumab irrespective of hormone receptor [status].”

“No safety concerns or late cardiac safety signals emerged,” Dr Jackisch added.

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Administration of the HER-2-receptor-targeting recombinant monoclonal antibody trastuzumab (T) concurrently or after adjuvant chemotherapy can prolong overall survival (OS) and disease-free survival (DFS) among women with HER2-positive (HER2+) early breast cancer (EBC).

“HERA (BIG 1-01) is an international, multicenter, phase 3 randomized trial involving 5102 women with HER2-positive EBC either nodal negative (tumor-size ≥ 1cm) or nodal positive,” Dr. Jackisch said. “After completion of primary therapy, including surgery, chemotherapy and radiotherapy as indicated, patients were randomly assigned to receive trastuzumab every 3 weeks for 1 year, or for 2 years, or to observation.”

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At a median followup of 11.0 years, survival benefits were found for trastuzumab (1- or 2-years) over those achieved in the observation cohort (trastuzumab 1-year vs observation: hazard ratio [HR] 0.74; 95% CI: 0.65-0.86; P < .0001).

There was no significant difference in survival between the trastuzumab 1- and 2-year study groups, however.


  1. Jackisch C, Piccart MJ, Gelber RD, et al. THERA trial: 10 years follow up of trastuzumab after adjuvant chemotherapy in HER2 positive early breast cancer – Final analysis. Oral presentation at: San Antonio Breast Cancer Symposium 2015; December 10, 2015; San Antonio, TX.