Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Breast Cancer, HR+/HER2- breast cancer, Palbociclib, Breast Neoplasms

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance Foundation Trials, LLC.
ID
NCT02513394
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
About 5796 people participating
Last Updated