drugset / Trial / NCT05415215
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Timeline
- Start
- 2022-07-05
- Primary completion
- 2024-11-20
- Completion
- 2025-11-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Subcutaneous |
| Subject | Pertuzumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Subcutaneous |
| Subject | Trastuzumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | Intravenous |
| Background | rHuPH20 | Protein / enzyme biologic | 20000 iu | Subcutaneous |