6/28/23, 11:03 PM HERA Pathway Feedback Search Clinical Topics Home Studies HERA HERA Trial question Is one year of treatment with trastuzumab after adjuvant chemotherapy superior to observation in female patients with HER2-positive breast cancer? Study design Multi-center Open label RCT Population 3387 female patients Inclusion criteria: female patients with HER2-positive breast cancer Key exclusion criteria: distant metastases, a previous invasive breast carcinoma, clinical stage T4 tumors, including inflammatory breast cancers or involvement of supraclavicular nodes Interventions N=1694 trastuzumab (at a dose of 8 mg/kg of body weight IV once, then at a dose of 6 mg/kg every three weeks for 1 year) N=1693 observation alone (no treatment) Primary outcome Recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death 13.0 % 13 9.8 % 7.5 6.5 % Significant decrease 3.3 % NNT = 18 0.0 % Trastuzumab Observation alone Significant decrease in recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death (7.5% vs. 13%; HR 0.54, 95% CI 0.43 to 0.67) Secondary outcomes No significant difference in death from any cause (1.7% vs. 2.2%; HR 0.76, 95% CI 0.47 to 1.23) https://web.pathway.md/studies/recmy5vQHAkMIT6iQ 1/2 6/28/23, 11:03 PM HERA Pathway Significant decrease in distant recurrence (5% vs. 9.1%; HR 0.49, 95% CI 0.38 to 0.63) Safety outcomes Significant differences in severe congestive HF (0.54% vs. 0%, p = 0.002). Conclusion In female patients with HER2-positive breast cancer, trastuzumab was superior to observation alone with respect to recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant cancer, or death. Reference Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. Open reference URL https://web.pathway.md/studies/recmy5vQHAkMIT6iQ 2/2