Trial ID or NCT#

NCT01864746

Status

NOT RECRUITING

Purpose

The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

Official 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 "PENELOPEB"

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Irene Wapnir
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery) at the Stanford University Medical Center
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Assistant Professor of Medicine (Oncology) at the Stanford University Medical Center
Douglas W. Blayney, MD, FACP
Medical oncologist, Breast specialist
Professor of Medicine (Oncology) at the Stanford University Medical Center
Suleiman Alfred Massarweh, MD
Medical oncologist, Breast specialist
Associate Professor of Medicine (Oncology) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Caitline Plahn
(650) 723-3046