Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC)
Status:
Completed
Trial end date:
2015-01-15
Target enrollment:
Participant gender:
Summary
This is a phase I study to evaluate the safety and define the pharmacokinetic (PK) profile of
orally administered reparixin in combination with paclitaxel in HER 2 (Human epidermal growth
factor receptor-2) negative metastatic breast cancer patients.
The primary objective of this study was to evaluate the safety and define the pharmacokinetic
(PK) profile of orally administered reparixin in combination with paclitaxel in HER-2
negative MBC patients.
The secondary objectives were to:
1. Evaluate the effects of orally administered reparixin on cancer stem cell (CSC) markers,
the tumoral microenvironment and markers of cytokine inflammation;
2. Evaluate peripheral blood samples for enumeration of circulating tumor cells (CTCs),
molecular characterization as CSCs and perform epithelial-mesenchymal transition (EMT)
biomarker profiling;
3. Assess disease response for indication of efficacy.