Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients with Primary Inflammatory Breast Cancer (IBC) without HER2 Overexpression
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitexal), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
Treatment Location: N/A
Primary Objectives is to determine the pathologic complete response (CR) rate in patients with primary inflammatory breast cancer (IBC) without HER2 overexpression by Panitumumab, Nab-paclitaxel, and Carboplatin (PNC) and FEC preoperative systemic chemotherapy. Secondary Objectives 1.To determine the disease-free survival (DFS) produced by PNC regimens. 2.To determine the overall survival (OS) produced by PNC regimens. 3.To determine the disease-free survival (DFS) produced by PNC regimens among patients with triple negative breast cancer. 4.To determine the overall survival (OS) produced by PNC regimens patients with triple negative breast cancer. 5.To determine the safety and tolerability by PNC regimens. 6.To determine whether pathologic response rate correlates with EGFR expression level. Exploratory 1.To identify molecular markers predictive of pathologic CR rate by analysis of multilayer immunohistochemical staining (IHC). 2.To identify molecular marker by gene profiling and proteinomics.
IRB Review and Approval Date: 11/01/2010
Recruitment Status: Closed
Projected Accrual: N/A