Clinical trial
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment…
NCT02492711 · MacroGenics, Industry · Completed
Key facts
| NCT number | NCT02492711 |
|---|---|
| Title | Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer |
| Official title | A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment |
| Acronym | SOPHIA |
| Lead sponsor | MacroGenics, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | HER-2 Positive Breast Cancer, Metastatic Neoplasm |
| Intervention type | Biological, Drug |
| Interventions | Margetuximab, Trastuzumab, Physician's choice of chemotherapy. |
| Enrollment | 624 |
| Start date | Aug 24, 2015 |
| Primary completion | Aug 11, 2021 |
| Completion | Jun 14, 2022 |
| First posted | Jul 9, 2015 |
| Last update posted | Mar 17, 2025 |
| Countries | Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Poland and 6 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: