Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer

Exclusion criteria

• ✕. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2), left ventricular ejection fraction (LVEF) \< 50% or local lower limit of normal as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled hypertension (refer to the European Society of Cardiology and European Society of Hypertension guidelines \[Williams et al., 2018\])
• ✕. Presence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥ 2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality
• ✕. Unstable angina pectoris or acute myocardial infarction ≤ 3 months prior to first dose of study drug
• ✕. Corrected QT interval Fredericia (QTcF) \> 470 msec (males and females). Note: If the QTcF is \> 470 msec in the first electrocardiogram (ECG), a total of 3 ECGs separated by at least 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤ 470 msec, the subject meets eligibility in this regard.
• ✕. Known history of congenital long QT syndrome