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CLINICAL TRIALS
About Clinical Trials Find a Clinical Trial
CLINICAL TRIALS
About Clinical Trials Find a Clinical Trial

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

Trial ID or NCT#

NCT01864746

Status

not recruiting iconNOT 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, MD
Irene Wapnir, MD
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery)
Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Associate Professor of Medicine (Oncology)
Douglas W. Blayney
Douglas W. Blayney
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)

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

CONTACT

Caitline Plahn
(650) 723-3046

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View on ClinicalTrials.gov