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PALbociclib CoLlaborative Adjuvant Study

NCT02513394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5796

Last updated 2026-02-10

Study results available
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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

Interventions

DRUG

Palbociclib

DRUG

Standard Adjuvant Endocrine Therapy

Sponsors & Collaborators

  • Austrian Breast & Colorectal Cancer Study Group

    collaborator NETWORK

  • NSABP Foundation Inc

    collaborator NETWORK

  • PrECOG, LLC.

    collaborator OTHER

  • Breast International Group

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Alliance Foundation Trials, LLC.

    lead OTHER

Principal Investigators

  • Evanthia Galanis, MD · Alliance Foundation Trials, LLC.

  • Erica Mayer, MD · Dana-Farber Cancer Institute

  • Angela DeMichele, MD · University of Pennsylvania

  • Michael Gnant, MD · ABCSG, Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-11-30
Completion
2028-12-31

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513394 on ClinicalTrials.gov