NCT02513394

PALbociclib CoLlaborative Adjuvant Study

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,796 (actual)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib
DRUG	Standard Adjuvant Endocrine Therapy

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-11-01
• Completion: 2028-12-01
• First posted: 2015-07-31
• Last updated: 2026-02-10
• Results posted: 2022-04-13

Locations

437 sites across 21 countries: United States, Australia, Austria, Belgium, Canada, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom