Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients

Exclusion Criteria

• •1. Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy or hormonotherapy.
• •2. Patients receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine treatment, or radiotherapy for the currently diagnosed tumor.
• •3. Known hypersensibility to abemaciclib or any of its components.
• •4. Difficulty to swallow oral medication.
• •5. Serious uncontrolled concomitant disease that would put the patient at high risk for treatment-related complications.
• •6. Patients whose general clinical condition does not consider postponing surgery.
• •7. Inadequate organ function, evidenced by the following laboratory results:
• •* Absolute neutrophil count \<1,500 cells/mm3
• •* Platelet count \<100,000 cells/mm3
• •* Hemoglobin \<8 g/dL
• •* Total bilirubin greater than 1,5 times the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
• •* Aspartate aminotransferase (AST \[SGOT\]) or alanine aminotransferase (ALT \[SGPT\]) \>3 x ULN
• •* Serum creatinine \>2 mg/dL and/or clearance creatinine \<50mL/min (calculated by Cockcroft-Gault method)
• •8. Patients with serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis).
• •9. Patients with a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
• •10. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
• •11. Pregnant or breastfeeding patients