Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
AstraZeneca
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
