drugset / Trial / NCT02586025
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
RandomizedParallel-groupTriple-blindTreatment
Summary
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve participants with early-stage or locally advanced HER2-positive breast cancer. The anticipated treatment duration is approximately 17 months.
Timeline
- Start
- 2016-03-14
- Primary completion
- 2017-10-23
- Completion
- 2022-03-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 90 mg/m2 | — |
| Background | Epirubicin | Small molecule | 120 mg/m2 | — |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |