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)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Celgene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

ABI-007-MBC- 001 is a Phase 2/3, multicenter, open-label, randomized, study that will compare the safety and efficacy of weekly nab-paclitaxel in combination with gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line therapy in female subjects with Estrogen Receptor (ER), Progesterone Receptor (PgR), and human epidermal growth factor receptor 2 (HER2) negative (triple negative) metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer. In the phase 2 portion of the study, the combinations of nab-paclitaxel plus gemcitabine and nab-paclitaxel plus carboplatin will be evaluated, and a comparator arm of gemcitabine combined with carboplatin will be used. In the phase 3 portion of the study, the selected nab-paclitaxel combination treatment will be compared to gemcitabine combined with carboplatin to evaluate progression free survival, safety and tolerability, overall survival, disease control rate and duration of response in women with metastatic triple negative breast cancer. Due to changes in the treatment landscape since the initiation of this trial, the decision was made not to proceed to the Phase 3 portion of the study.

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

Type	Name	Description
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.

Timeline

• Start date: 2013-09-26
• Primary completion: 2016-10-28
• Completion: 2016-10-28
• First posted: 2013-06-19
• Last updated: 2019-02-21
• Results posted: 2018-03-08

Locations

140 sites across 12 countries: United States, Australia, Austria, Brazil, Canada, France, Germany, Greece, Italy, Portugal, Spain, United Kingdom