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This study (PALOMA-2) compares Palbociclib (PD-0332991) plus Letrozole with Letrozole alone as first-line treatment in postmenopausal women with estrogen receptor-positive, HER2-negative advanced breast cancer. It included patients with no prior systemic therapy for advanced disease. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.