drugset / Trial / NCT04024462
A 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 Chinese Participants With HER2-Positive Early Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV) and trastuzumab IV formulations in Chinese participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.
Timeline
- Start
- 2020-02-05
- Primary completion
- 2021-12-13
- Completion
- 2026-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Background | Tamoxifen | Small molecule | — | — |