Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Primary Objective: To determine the MTD and RP2D of LDE225 administered orally in combination with docetaxel in TN ABC patients. Primary End-point: To determine the incidence rate of DLT within the first two cycles of LDE225 in combination with docetaxel at each dose level. Secondary Objectives: * To determine the safety and tolerability of LDE225 given in combination with docetaxel. * To characterize the effects of LDE225 in combination with docetaxel on corrected QT (QTc) intervals and their correlation with systemic drug exposure. * To evaluate the efficacy of the combination of docetaxel with LDE225 in TN ABC patients. * To evaluate the Pharmacokinetics (PK) of the combination of docetaxel with LDE225. Secondary End-points: * Safety will be assessed by standard clinical and laboratory tests (hematology, serum chemistry). Adverse events grade will be defined by the NCI CTCAE v4.0. * Changes in QT/QTc from baseline ECG values and correlation with systemic drug exposure. * The efficacy endpoints are Time To Progression (TTP) and Objective Response Rate (ORR). TTP is measured from the initiation of treatment till disease progression and ORR is defined by RECIST 1.1 criteria as complete response rate + partial response rate. * The PK will determine whether LDE225 influences the pharmacology of docetaxel. Blood samples will be taken at the times defined in the protocol. Exploratory Objectives: * To study potential predictive biomarkers of efficacy by evaluating activation of Hh signaling pathway and related pathways. * To analyze the pharmacodynamic (PD) treatment effects on the expression of Smo related biomarkers and Hg target genes in correlative samples. * To correlate biomarker, PD and PK findings with efficacy and toxicity data. Exploratory End-points: * Hh gene expression signature associated to pathway activation (at least Shh, Smo, Ptch1, Ptch2, Gli1, Gli2), analyzed in tumor samples. * Changes in Smo related pathway biomarkers (at least Gli1) in skin and blood correlative samples. * Pharmacodynamic and biomarker analysis results will be correlated with PK findings, efficacy and toxicity data. Demographics and Baseline Characteristics: Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. 95% confidence intervals will be provided for estimates of interest wherever possible. Safety Analyses: Adverse events data and serious adverse events will be reported in frequency tables (overall and by intensity). The safety analysis will be performed in the population that has received at least one dose of the drugs. Efficacy Analyses: Response will be analyzed in patients with measurable disease that have received at least one dose of the drugs. TTP will be evaluated in all patients that have received at least one dose of the drugs. Study population: Patient with hormonal receptors negative and HER2 negative ABC.