Clinical trial
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous…
NCT01566721 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT01566721 |
|---|---|
| Title | A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer |
| Official title | A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer |
| Acronym | SafeHER |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Neoplasms |
| Intervention type | Drug |
| Interventions | Herceptin |
| Enrollment | 2,577 |
| Start date | May 17, 2012 |
| Primary completion | Mar 10, 2015 |
| Completion | Feb 19, 2020 |
| First posted | Mar 29, 2012 |
| Last update posted | Apr 27, 2021 |
| Countries | Albania, Algeria, Argentina, Australia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia and 47 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: