Clinical trial
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant…
NCT01358877 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT01358877 |
|---|---|
| Title | A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer |
| Official title | A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer |
| Acronym | APHINITY |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Collaborators | Genentech, Inc. Industry Breast International Group |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Breast Cancer |
| Intervention type | Drug |
| Interventions | 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Paclitaxel, Pertuzumab, Placebo, Trastuzumab |
| Enrollment | 4,804 |
| Start date | Nov 8, 2011 |
| Primary completion | Dec 19, 2016 |
| Completion | Nov 28, 2024 |
| First posted | May 24, 2011 |
| Last update posted | Nov 28, 2025 |
| Countries | Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark and 30 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: