This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.
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Inclusion Criteria (phase lb): * Females with Breast cancer that is histologically or cytologically confirmed, HER2 negative and locally advanced or metastatic as confirmed by radiology * ECOG performance status 0 and 1 * Adequate bone marrow and organ function Exclusion Criteria (Phase lb): * Previous treatment with PI3K and/or mTOR inhibitors * Symptomatic Central Nervous System (CNS) metastases * Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment * Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug * Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF \> 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) * Inadequately controlled hypertension * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 and/or paclitaxel * Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists * Sensitivity to paclitaxel treatment * Uncontrolled diabetes mellitus * Pregnant or nursing (lactating) woman Other protocol-defined inclusion/exclusion criteria may apply