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Trial Summary

Protocol No.PRE0109
StatusOPEN TO ACCRUAL
Principal InvestigatorMiller, Kathy
ScopeNational
PhasePhase III
Age GroupAdult
TitlePALLAS: 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 [AFT-05]
DescriptionThis 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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • 18 years or older
  • Stage II or Stage III early invasive breast cancer
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast Cancer
Participating InstitutionsIU Health Arnett
    Indiana University (IU)
    • Eskenazi Hospital
    • IU Health North (For use by Cancer Center CTO only)
    • Indiana University Hospital / IU Simon Cancer Center
    • Spring Mill Medical Center
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu