Breast Cancer Clinical Trial
Official title:
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
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.
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.
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