Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: pharmacokinetic, safety and patients´ preference - substudy of the randomised phase III GAIN-2 study
This study was a multicentre, non-blinded, randomised substudy of the phase III multicentre, randomised GAIN-2 study (NCT01690702).
Standard of care for patients with early HER2-positive breast cancer is intravenously given trastuzumab in combination with chemotherapy.
Subcutaneous injection into the thigh demonstrated a comparable efficacy as intravenous formulation in different randomised studies.
In this study, patients were randomised to receive either subcutaneous trastuzumab into the thigh or into the abdominal wall after surgery.
Conclusion: Subcutaneous trastuzumab into the thigh compared to injection into the abdominal wall demonstarted 30% higher bioavailability.
Patients preferred subcutaneous injection of trastuzumab into the thigh as well as into the abdomal wall over intravenous injection.
Please read our new publication:
Reinisch M, Untch M, Mahlberg R, et al., Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study. The Breast, Volume 66, 2022,