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A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+ / HER2- Advanced Breast Cancer (PALOMA-2)

Trial Status: Closed to Accrual

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.

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.

California

Los Angeles
Translational Research In Oncology - US Inc
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Lia Etheridge
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

North Carolina

Durham
Duke University Medical Center
Status: WITHDRAWN

Oregon

Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ADMINISTRATIVELY_COMPLETE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID A5481008
  • Secondary IDs NCI-2013-00729, PALMOA-2, PALOMA-2, TRIO-022, 2012-004601-27
  • Clinicaltrials.gov ID NCT01740427