CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 191 enrolled
Drug / intervention
nab-Paclitaxel +2 moredrug
Likely dose
nab-Paclitaxel 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01881230
NCT01881230Phase 3Completed
CompareCT.gov

A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

Celgene·interventional·Posted Jun 19, 2013·Updated Feb 21, 2019

In Brief

A Phase 3 clinical trial evaluating nab-Paclitaxel, Carboplatin, and 1 other intervention for Breast Tumor and 10 related conditions. Completed, enrolled 191 participants across 140 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast 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
CountriesAustralia, Austria, Brazil, Canada, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 19, 2013
Enrollment StartSep 26, 2013
Primary CompletionOct 28, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.0 years ago

Interventions

nab-Paclitaxeldrug

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

Carboplatindrug

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

Gemcitabinedrug

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