Clinical Trial

PALbociclib CoLlaborative Adjuvant Study

Study acronym: PALLAS
Active, Not Recruiting Phase 3
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Summary
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.
Protocol Amendment History 41 amendments
This ClinicalTrials.gov record has been amended 41 times since 2015-07-30; most recent amendment 2026-06-11.
Status change: Recruiting → Active, Not Recruiting 2019-02-08
Status change: Not Yet Recruiting → Recruiting 2015-09-09
Trial Details
NCT Number NCT02513394
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Austrian Breast & Colorectal Cancer Study Group, NSABP Foundation Inc, PrECOG, LLC., Breast International Group, Pfizer
Conditions Breast Cancer
Enrollment 5,796 participants
Start Date 2015-08
Primary Completion 2020-11 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-15