Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the
primary objective of demonstrating the superiority of palbociclib in combination with
fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2
negative metastatic breast cancer whose disease has progressed after prior endocrine therapy.
The safety between the two treatment arms will also be compared. During study treatment, pre-
and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex®
or generic).
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
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