Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Inclusion criteria

• Female presenting with metastatic breast cancer.
• Tumor must have been tested by FISH/CISH for FGFR1 amplification.
• HER2 and HR status must have been determined.
• Patients must have HER2 negative breast cancer.
• Patients must have a documented disease progression as define by RECIST at baseline.
• Patients with HR+ disease:

• Must have received at least one prior endocrine therapy in the metastatic setting.
• Must have received no more than three lines of chemotherapy in the metastatic setting.
• Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.

Exclusion criteria

• Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
• Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

• History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
• Clinically significant resting bradycardia (< 50 beats per minute).
• LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
• Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
• Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.

Other protocol-defined inclusion/exclusion criteria may apply