LACOG 0313 - PENELOPE
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"
Invasive disease free survival (iDFS)
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.
Clinicaltrials.gov - NCT01864746
For more information visit BIG website
Phone: 55 51 3384 5334