Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The study is designed to compare the clinical benefit following treatment with letrozole in
combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal
women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti
cancer therapies for their advanced/metastatic disease.
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- Adult women with locoregionally recurrent or metastatic disease not amenable to
curative therapy.
- Confirmed diagnosis of ER positive breast cancer
- No prior systemic anti-cancer therapy for advanced ER+ disease.
- Postmenopausal women
- Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or
bone-only disease
- Eastern Cooperative Oncology Group [ECOG] 0-2
- Adequate organ and marrow function
- Patient must agree to provide tumor tissue
Exclusion Criteria:
- Confirmed diagnosis of HER2 positive disease
- Patients with advanced, symptomatic, visceral spread that are at risk of life
threatening complication in the short term
- Known uncontrolled or symptomatic CNS metastases
- Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from
completion of treatment.
- Prior treatment with any CDK 4/6 inhibitor.