MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2019-02-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Breast Tumor
  • Breast Cancer
  • Cancer of the Breast
  • Estrogen Receptor- Negative Breast Cancer
  • HER2- Negative Breast Cancer
  • Progesterone Receptor- Negative Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Triple-negative Breast Cancer
  • Triple-negative Metastatic Breast Cancer
  • Metastatic Breast Cancer

Interventions

DRUG

nab-Paclitaxel

nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.

DRUG

Carboplatin

Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Ileana Elias, M.D. · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881230 on ClinicalTrials.gov