Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Inclusion Criteria:

• Women 18 years or older with metastatic or locally advanced disease, not amenable tocurative therapy
• Confirmed diagnosis of HR+/HER2- breast cancer
• Any menopausal status
• Progressed within 12 months from prior adjuvant or progressed within 1 month fromprior advanced/metastatic endocrine breast cancer therapy
• On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing toswitch to goserelin (Zoladex ®) at time of randomization.
• Measurable disease defined by RECIST version 1.1, or bone-only disease
• Eastern Cooperative Oncology Group (ECOG) PS 0-1
• Adequate organ and marrow function, resolution of all toxic effects of prior therapyor surgical procedures
• Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

• Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent thatinhibits the PI3K-mTOR pathway
• Patients with extensive advanced/metastatic, symptomatic visceral disease, or knownuncontrolled or symptomatic CNS metastases
• Major surgery or any anti-cancer therapy within 2 weeks of randomization
• Prior stem cell or bone marrow transplantation
• Use of potent CYP3A4 inhibitors or inducers