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

LACOG 0715 - PALLAS

Registry

Clinicaltrials.gov: NCT02513394

Contact

lacog@lacog.org.br

Phone: 55 51 3384 5334