Clinical trial
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous…
NCT03493854 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT03493854 |
|---|---|
| Title | A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer |
| Official title | A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer |
| Acronym | FeDeriCa |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Early Breast Cancer |
| Intervention type | Drug, Procedure, Radiation |
| Interventions | Cyclophosphamide, Doxorubicin, Docetaxel, Paclitaxel, Pertuzumab IV, FDC of Pertuzumab and Trastuzumab SC, Trastuzumab IV, Trastuzumab SC, Surgery, Post-operative Radiotherapy and 1 more |
| Enrollment | 500 |
| Start date | Jun 14, 2018 |
| Primary completion | Jul 4, 2019 |
| Completion | Jun 2, 2023 |
| First posted | Apr 11, 2018 |
| Last update posted | Jun 26, 2024 |
| Countries | Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Russia and 7 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: