A Phase II Study of TKI258 (Dovitinib Lactate) as Salvage Therapy in Patients with Stage IV HER2-negative IBC and Local or Distant Relapse
The goal of this clinical research study is to learn if dovitinib can help to control inflammatory breast cancer. The safety of this drug will also be studied.
Treatment Location: N/A
Primary To determine an overall response (complete response [CR], partial response [PR] or stable disease [SD]) of dovitinib in patients with HER2-normal, local or distant relapse of metastatic inflammatory breast cancer Secondary · To evaluate safety analysis measures in terms of type, frequency and severity of adverse event reactions reported according to CTCAE v4.0 Exploratory Biomarkers: · To explore the predictive values of baseline FGFR-R1, and VEGF-R1, signaling in tumor tissue (primary tumor or metastasis) before and during treatment with dovitinib. · To determine the effect of dovitinib on the presence of CTC and CTCs with epithelial and/or EMT gene expression in PB. To collect and archive biopsy tumor tissue, serum and plasma for later hypothesis generating associations
IRB Review and Approval Date: 01/27/2012
Recruitment Status: Closed
Projected Accrual: N/A