A Phase 2, Randomized, Open-Label Study of Lucitanib in Patients with Fgf Aberrant Metastatic Breast Cancer.

TPS628 Background: Lucitanib is a potent, oral inhibitor of the tyrosine kinase activity of Fibroblast Growth Factor Receptors 1-3 (FGFR1-3), Vascular Endothelial Growth Factor Receptors 1-3 (VEGFR1-3) and Platelet-Derived Growth Factor Receptors α/β (PDGFRα/β). FGF aberrancy is a hallmark genomic alteration observed in up to 25% of patients with breast cancer and is defined by amplification of FGFR1, and or 11q (containing FGF ligands 3, 4, 19, and CyclinD1). In a recent phase 1/2 clinical trial of lucitanib at daily doses of 5 to 20 mg, heavily pretreated patients with advanced breast cancer patients and FGF aberrancy experienced an objective response rate (ORR) of 50% and a median progression-free survival (PFS) of over 9 months (Soria et al, 2014). This compelling clinical activity has led to the initiation of a global clinical development program for lucitanib in breast cancer. Methods: The current phase 2 study was designed to evaluate the efficacy and safety of 2 different doses (10 and 15 mg) of l...