Subcutaneous trastuzumab: development of a new formulation for treatment of HER2-positive early breast cancer

Figures & data

Table 1 Clinical trials of subcutaneous trastuzumab in patients with HER2+ early stage breast cancer

Trial name (clinicaltrials.gov identifier)	Study design	Treatment	n	Primary outcome	Other outcomes
NCT00800436	Phase I Open-label, two-part, dose-finding and dose confirmation study	Part 1: dose-finding iv: 6 mg/kg SC: 6 mg/kg; 10 mg/kg; 8 mg/kg Part 2: dose confirmation SC: 8 mg/kg; 12 mg/kg	66 including 24 healthy male volunteers	8 mg/kg SC resulted in exposure comparable with that obtained with 6 mg/kg iv	Subjects with at least 1 AE iv: 11/12 (92%) SC: 55/58 (95%) No SAE
HannaH (NCT00950300)	Phase III Noninferiority, randomized, open-label, study	600 mg SC + chemotherapy 6 mg/kg iv + chemotherapy	596	SC was noninferior to iv in terms of Ctrough and pCR	Patients with at least 1 AE iv: 280/298 (94%) SC: 289/297 (97%) Patients with at least 1 SAE iv: 37/298 (12%) SC: 62/297 (21%)
PrefHer (NCT01401166) Ongoing trial	Phase II Randomized, crossover study with two cohorts	Cohort 1 with crossover 600 mg SC using a vial 6 mg/kg IV Cohort 2 with crossover 600 mg SC using a ready to use injection device 6 mg/kg IV	400	Patients’ preference	Health care professional satisfaction with SC
SafeHer (NCT01566721) Ongoing trial	Phase III Two-cohort open label study	SC by assisted administration SC by self-administered by single-use injection device	2500	Incidence of adverse events	DFS Patient satisfaction with SC Single use injection device

Abbreviations: SC, subcutaneous trastuzumab; iv, intravenous trastuzumab; C_trough, trastuzumab serum trough concentration; pCR, pathologic complete response; AE, adverse event; SAE, serious adverse event; DFS, disease-free survival.