drugset
drugset / Trial / NCT02229149

Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer

NCT02229149 ↗

Phase 2 Terminated 33 enrolled US Oncology Research Genentech, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane \[paclitaxel, docetaxel or nab paclitaxel\] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.

Timeline

Start
2014-12
Primary completion
2022-01
Completion
2022-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Background Capecitabine Small molecule 1500 mg Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications

breast cancer