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 to
curative therapy

- Confirmed diagnosis of HR+/HER2- breast cancer

- Any menopausal status

- Progressed within 12 months from prior adjuvant or progressed within 1 month from
prior advanced/metastatic endocrine breast cancer therapy

- On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to
switch 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 therapy
or 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 that
inhibits the PI3K-mTOR pathway

- Patients with extensive advanced/metastatic, symptomatic visceral disease, or known
uncontrolled 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