Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

• Drug: Palbociclib
  
  Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
  Other Name: Ibrance
• Drug: Letrozole
  
  Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
  Other Name: Femara

Inclusion Criteria:

• Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
• ER-positive and/or PR-positive tumor based on local laboratory results
• HER2-negative tumor based on local laboratory results
• Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)

Exclusion Criteria:

• Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor