Clinical Trials
LACOG 0715 - PALLAS
Title
PALLAS: PALbociclib CoLlaborative Adjuvant Study:
A randomized phase III trialof palbociclib with adjuvant endocrine
therapy versus endocrine therapy alone for hormone receptor positive
(HR+)/ human epidermal growth factor receptor 2 (HER2)-negative
early breast Cancer
Primary Objective
To compare invasive disease-free survival (iDFS) for the
combination of at least 5 years of endocrine therapy plus 2 years of
palbociclib treatment versus at least 5 years endocrine therapy
alone in patients with histologically confirmed HR-positive/HER2-
negative early breast cancer (EBC).
Design
This is a prospective, international, multicenter, randomized, openlabel
Phase III study evaluating the addition of 2 years of palbociclib to
at least 5 years of standard adjuvant endocrine therapy for patients
with HR+/ HER2-negative EBC.
Sample size: required: N=4600
Sponsor: ALLIANCE for Clinical Trials in Oncology (US), ABSCG Austrian Breast &
Colorectal Cancer Study Group (ROW)
Status: Open. Regulatory process in Mexico.
LACOG Study Coordinator: Gustavo Werutsky
Registry
Clinicaltrials.gov: NCT02513394
Contact
lacog@lacog.org.br
Phone: 55 51 3384 5334