drugset / Trial / NCT02194166

A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration

NCT02194166

Phase 3 Completed 90 enrolled Hoffmann-La Roche
RandomizedCrossoverOpen-labelTreatment

Summary

This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous \[IV\] and 14 cycles of SC trastuzumab).

Timeline

Start
2014-07-18
Primary completion
2018-07-12
Completion
2018-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 600 mg Intravenous
Background Docetaxel Small molecule
Background Paclitaxel Small molecule

Indications