Clinical Trials

LACOG 0313 - PENELOPE

Title

Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, Her2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy - "PENOLOPE"

Primary Objective

Invasive disease free survival (iDFS) 

Design

Thi is a prospective, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study comparing the efficacy and the safety of thirteen cycles (1year) adjuvant treatment with palbociclib versus placebo in high risk (CPS-ER score 3-6) patients without pathological complete response after neoadjuvant chemotherapy for hormone-recpetor-positive/HER2-normal primary breast cancer.

Sample size: 800

LACOG Study Coordinator: Gustavo Werutsky

Status: Open. Regulatory process in Brazil.

Sponsor: GBG

LACOG 0313 - PENELOPE

Registry

Clinicaltrials.gov - NCT01864746

BIG 1-1

For more information visit BIG website

Contact

lacog@lacog.org.br

Phone: 55 51 3384 5334