drugset / Trial / NCT02040935

A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants

NCT02040935

Phase 3 Completed 128 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).

Timeline

Start
2014-02-21
Primary completion
2018-09-14
Completion
2018-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 600 mg Subcutaneous

Indications