Randomized Phase II Study to Assess PD 0332991 in Breast Cancer

Exclusion Criteria

• •1. Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy or hormonotherapy.
• •2. Patients with previously treated breast cancer during the last 5 years or receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine
• •4\. Known hypersensibility to PD0332991 or any of its components. 5. Difficulty to swallow oral medication 6. Serious uncontrolled concomitant disease that would put the patient at high risk for treatment-related complications.
• •7\. Patient whose general clinical condition does not consider postponing surgery 8. Inadequate organ function, evidenced by the following laboratory results:
• •Absolute neutrophil count \<1,500 cells/mm3
• •Platelet count \<100,000 cells/mm3
• •Hemoglobin \<9 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 \[SGPT\]) \>2.5 x ULN
• •Serum creatinine \>2.0 mg/dL and/or 177 μmol/L clearance creatinine \<50mL/min (calculated by Cockcroft-Gault method)
• •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) \>1.5 x ULN (unless on therapeutic coagulation) 9. Uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \> 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; CHF of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication.
• •10\. Patients with a history of long-QT syndrome or documented family history of long-QT syndrome.
• •11\. QTc \>470 12. serum potassium level \< LLN 13. Uncontrolled intercurrent illness including but not limited to, known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus or psychiatric illness/social situations that would limit compliance with study requirements.
• •14\. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
• •15\. Pregnant or breastfeeding patients