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#
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.
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
- - 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.
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