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; Ctrough, trastuzumab serum trough concentration; pCR, pathologic complete response; AE, adverse event; SAE, serious adverse event; DFS, disease-free survival.