drugset / Trial / NCT01881230

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)

NCT01881230

Phase 2/3 Completed 191 enrolled Celgene Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

Timeline

Start
2013-09-26
Primary completion
2016-10-28
Completion
2016-10-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 2 unknown Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous