Overview

PALbociclib CoLlaborative Adjuvant Study

Status:
Active, not recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Alliance Foundation Trials, LLC.
Collaborators:
Austrian Breast & Colorectal Cancer Study Group
Breast International Group
NSABP Foundation Inc
Pfizer
PrECOG, LLC.
Treatments:
Hormones
Mitogens
Palbociclib