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 ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Eligibility 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
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
