- Final results of the phase 3 HannaH trial confirm that subcutaneous (SC) trastuzumab is comparable in safety and efficacy to intravenous (IV) trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
Why this matters
- SC trastuzumab is preferred by patients by virtue of shorter treatment times, potentially lower costs, and increased convenience.
- Open-label, multicenter, international neoadjuvant-adjuvant randomized, phase 3 noninferiority clinical trial (n=596).
- Patients randomly assigned to fixed-dose SC trastuzumab (600 mg) or IV trastuzumab (loading dose 8 mg/kg, then maintenance dose 6 mg/kg) every 3 weeks for 8 cycles with neoadjuvant chemotherapy+an additional 10 cycles of SC or IV trastuzumab after surgery in the adjuvant setting for a total of 1 year of anti-HER2 therapy.
- Funding: F. Hoffmann-LaRoche Ltd.
- Median follow-up was 5.9 years.
- No difference between SC and IV groups:
- 6-year event-free survival (EFS; 65% vs 65%; HR, 0.98; 95% CI, 0.74-1.29).
- 6-year OS (84% vs 84%; HR, 0.94; 95% CI, 0.61-1.45).
- Safety was comparable across groups:
- incidence of adverse events (SC vs IV: 97.6% vs 94.6%);
- grade ≥3 adverse events (53.2% vs 53.7%);
- cardiac events (14.8% vs 14.1%); and
- serious adverse events (21.9% vs 15.1%).
- Open-label design.