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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Docetaxel | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |