CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 5,796 enrolled
Drug / intervention
Palbociclib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02513394
NCT02513394Phase 3Active

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

Alliance Foundation Trials, LLC.·interventional·Posted Jul 31, 2015·Updated Jun 15, 2026

In Brief

A Phase 3 clinical trial evaluating Palbociclib and Standard Adjuvant Endocrine Therapy for Breast Cancer. Active but no longer recruiting, targeting 5,796 participants across 437 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Canada, Germany, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Timeline

Phase 3Active
20162017201820192020202120222023202420252026202720282029
First PostedJul 31, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 1, 2020
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.9 years ago

Interventions

Palbociclibdrug

Standard Adjuvant Endocrine Therapydrug