PALLAS: PALbociclib CoLlaborative Adjuvant Study
PALLAS: PALbociclib CoLlaborative Adjuvant Study
Sponsor: AFT (USA), ABCSG (Non-USA)
A cooperation between BIG, GBG, NSABP, PrECOG
Introduction
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.
News
Recruitment has ended.
Design
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
Study objectives:
Primary:
- To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC).
Secondary:
- To compare the following endpoints: iDFS excluding second primary invasive cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS).
- To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.
The inclusion and exclusion criteria, as well as more detailed information on the study design, can be found in the short protocol on the list of documents.
Further information on the study at clinicaltrials.gov
Study Documents
Participating trial centers receive the internal documents in the Pallas-Portal.
Contact
Dr. Karin Hesse
