Clinical trial NCT01881230
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
Keywords: Breast Cancer Cancer of the Breast Metastatic Breast Cancer Metastatic Triple Negative Breast Cancer Triple Negative Breast Cancer Triple Negative Metastatic Breast Cancer Basal-like breast cancer Hormone receptor negative breast cancer Estrogen receptor negative breast cancer Progesterone negative receptor breast cancer HER2 Negative Breast Cancer Abraxane nab-Paclitaxel ABI-007 gemcitabine Gemzar carboplatin Paraplatin Paraplatin AQ Phase 2 Phase 3
Sponsor: Celgene
Start date: 2013-09-26; Completion date: 2016-10-28
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Treatment Arm A: nab-Paclitaxel 125 mg/m\^2 by intravenous (IV) administration over 30 minutes, followed by gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle by IV administration over 30 minutes arm 2: Treatment Arm B: nab-Paclitaxel 125 mg/m\^2 on Days 1 and 8 by IV administration followed by carboplatin at an Area Under the Curve (AUC) of 2 on Days 1 and 8 of each 21-day cycle by IV administration arm 3: Treatment Arm C: Gemcitabine 1000 mg/m\^2 on Days 1 and 8 by IV administration followed by carboplatin AUC 2 on Days 1 and 8 of each 21-day cycle by IV administration
Interventions: intervention 1: nab-Paclitaxel intervention 2: Carboplatin intervention 3: Gemcitabine
Intervention descriptions: intervention 1: nab-Paclitaxel 125 mg/m\^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle. intervention 2: Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration intervention 3: Gemcitabine 1000 mg/m\^2 on Days 1 and 8 of each 21-day treatment cycle.

Protocol documents: