• To assess the efficacy of reparixin compared to placebo in limiting CRF in adult patients with locally advanced or metastatic breast cancer undergoing single-agent taxane chemotherapy, using FACITFatigue scale.
The secondary objectives are:
To evaluate change in Quality of Life in the two treatment arms
To assess the percentage of patients treated with reparixin compared to placebo delaying and discontinuing chemotherapy
To assess Patient Global Impression of Severity (PGI-S) score and Patient Global Impression of Change (PGI-C) score associated with reparixin compared to placebo
To assess the effect of reparixin compared to placebo on ECOG PS
To assess the effects of reparixin vs placebo on Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS)
The safety objective is:
• To assess the safety and tolerability of reparixin in adult patients undergoing taxane-containing chemotherapy.
The pharmacokinetic (PK) objective is:
• To define the PK profile of orally administered reparixin, its metabolites (DF2243Y, DF2188Y, ibuprofen) and concomitant antineoplastic agents (paclitaxel, or nab-paclitaxel or docetaxel) in adult patients with locally advanced or metastatic breast cancer.