Hera Trial: 10 Years Follow Up Of Trastuzumab After Adjuvant Chemotherapy In Her2 Positive Early Breast Cancer Final Analysis

Background: Trastuzumab (T), a recombinant monoclonal antibody against HER-2 receptor, significantly improves overall (OS) and disease-free survival (DFS) in women with HER2 positive (HER2+) early breast cancer (EBC) when administered concurrent with or sequentially after adjuvant chemotherapy. Material and Methods: HERA (BIG 1-01) is an international, multicenter, phase III randomized trial involving 5102 women with HER2-positive (HER2+) EBC either nodal negative (tumor-size ≥ 1cm) or nodal positive. After completion of primary therapy, including surgery, chemotherapy and radiotherapy as indicated, patients (pts.) were randomized to T every 3 weeks for 1 yr, 2 years (yrs), or observation. Primary endpoint is DFS and secondary endpoints are OS and time to distant recurrence (TTDR). Here, we are presenting the HERA final analysis after 10 years of follow-up. Results: The clinical data cut-off for this final analysis of the HERA trial is June 2015. Data are being cleaned and final safety and efficacy analyses will be available for presentation at the meeting. Cardiac toxicity remained low and occurred mostly during the treatment phase. Citation Format: Jackisch C, Piccart MJ, Gelber RD, Procter M, Goldhirsch A, DeAzambuja E, Castro Jr G, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, Mcfadden E, Leyland-Jones B, Bell R, Dowsett M, Cameron D. HERA trial: 10 years follow up of trastuzumab after adjuvant chemotherapy in HER2 positive early breast cancer – Final analysis. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr PD5-01.