Clinical trial
A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of…
NCT00950300 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT00950300 |
|---|---|
| Title | A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer |
| Official title | A Phase III, Randomized Open-Label Study to Compare the Pharmacokinetics, Efficacy, and Safety of Subcutaneous (SC) Trastuzumab With Intravenous (IV) Trastuzumab Administered in Women With HER2-Positive Early Breast Cancer (EBC) |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Cancer |
| Intervention type | Drug |
| Interventions | 5-Fluorouracil, Cyclophosphamide, Docetaxel, Epirubicin, Herceptin IV [trastuzumab], Herceptin SC [trastuzumab] |
| Enrollment | 596 |
| Start date | Oct 16, 2009 |
| Primary completion | Jul 12, 2011 |
| Completion | Jan 24, 2017 |
| First posted | Jul 31, 2009 |
| Last update posted | Jan 23, 2018 |
| Countries | Argentina, Brazil, Canada, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, Israel and 14 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: