CARE Initiative: Real-world Emulation of the PALOMA-2 Trial

Exclusion Criteria

• •Human epidermal growth factor receptor 2 (HER2) positive tumor
• •Diagnosis of brain, central nervous system, and/or spinal cord metastases
• •Neoadjuvant or adjuvant treatment with anastrozole or letrozole ≤12 months before metastatic diagnosis
• •Prior treatment with treatment with ribociclib, abemaciclib, or palbociclib
• •Treatment with a CYP3A4 inhibitor or inducer or drugs known to prolong the QT interval, as specified in the PALOMA-2 trial protocol, in the 7 days prior to study treatment initiation
• •Anti-cancer therapy or major cancer-related surgery within 2 weeks before study treatment initiation
• •Diagnosis of a second primary malignancy within 3 years prior to study treatment initiation
• •Diagnosis of long or short QT syndrome, Brugada syndrome, QTc prolongation, or Torsade de Pointes
• •Diagnosis of hypocalcemia, hypokalemia, or hypomagnesemia
• •Diagnosis of myocardial infarction, angina, ongoing cardiac dysrhythmias, atrial fibrillation, congestive heart failure, cerebral infarction, transient ischemic attack, or pulmonary embolism in the 6 months prior to study treatment initiation
• •Diagnosis of inflammatory bowel disease chronic diarrhea, or short bowel syndrome
• •Diagnosis of human immunodeficiency virus infection