Clinical Trial Details

PALLAS

PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Breast Cancer
Study Type: Interventional
Phase: Phase III
Study Start Date: 07/29/2015
Study Completion Date: 09/30/2025

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbocicilib to standard adjuvant endocrine therapy for patients with HR+/HER2 early breast cancer (EBC). The purpose of the PALLAS study is to determine weather 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 the palbociclib on genomically defined tumor subgroups, is planned.

NCT Number

NCT02513394

Principal Investigator(s)

Carolyn Hendricks, MD

Sponsor(s)

Alliance Foundation Trials, LLC

Participant Eligibility

• Age: 18 - No Maximum
• Gender: Male, Female