Clinical Trials

PENELOPE (JBCRG-21)
GLOBAL This trial is a collaborative study with GBG.

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”

Status
No Longer Recruiting

Objectives
To compare invasive disease free survival (iDFS) for albociclib vs. placebo in patients with residual invasive breast cancer and high CPS-EG score - after neoadjuvant chemotherapy receiving standard adjuvant endocrine therapy for HR- positive/HER2-normal primary breast cancer.

Subjects

Endpoints
Invasive disease free survival (iDFS)

Trial Period

Lead Principal Investigator

Target Sample Size
45

Regimen
palbociclib 125 mg vs Placebo

Source of Funding
GBG Forschungs GmbH

Conference Presentation

Articles and Publications

UMIN-ID
UMIN000015779

jRCT

Memo

COI Disclosure

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