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Study for Patients with HR+/HER2- Early Breast Cancer

Clinical Trial Title: 
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.
Clinical Trial Protocol ID: 
16042003
Clinical Trial Investigator Name: 
Melody A. Cobleigh, MD
Clinical Trial Protocol Description: 

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 (PALbociclib CoLlaborative Adjuvant Study) 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.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Be randomized within 12 months of histological diagnosis and within 6 months of starting adjuvant endocrine therapy.
  • Have sufficient resolution of all side effects from chemotherapy, radiation therapy and surgery.
  • Have stage II or III breast cancer.
  • Have no clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, cirrhosis, etc.

This is a partial list of elgibility requirements.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-3732
Contact Name: 
Chrystie Paul, RN, BSN