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

NCT02586025

Phase 3 Completed 329 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
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

Indications