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.
- 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
- 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.
Translational Research In Oncology - US Inc (TRIO-US)
UCLA / Jonsson Comprehensive Cancer Center
Contact: Lia Etheridge
USC / Norris Comprehensive Cancer Center
Stanford Cancer Institute Palo Alto
UCSF Medical Center-Mount Zion
District of Columbia
MedStar Georgetown University Hospital
Emory University Hospital / Winship Cancer Institute
University of Maryland / Greenebaum Cancer Center
University of Michigan Comprehensive Cancer Center
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Duke University Medical Center
OHSU Knight Cancer Institute
M D Anderson Cancer Center
Fred Hutch / University of Washington Cancer Consortium
University of Wisconsin Carbone Cancer Center
Trial Phase Phase III
Trial Type Treatment
- Primary ID A5481008
- Secondary IDs NCI-2013-00729, 2012-004601-27, PALMOA-2, PALOMA-2, TRIO-022
- Clinicaltrials.gov ID NCT01740427