West Cancer Center

BREAST: Metastatic; ER/PR+, HER2-; Any line; "A5481034 EAP"

An expanded access study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor positive, HER2 negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

Title

Pfizer A5481034

Study Title

Site Link

NCT02142868

Malignancy

Breast: Metastatic Breast

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Any

Investigational Agent

Palbociclib

Drug Class

CDK4/6 inhibitor

Lee Schwartzberg, MD

Sponsor

Pfizer

Phase

Phase 4

Status

Closed to Accrual

Key Eligibility Criteria

https://www.clinicaltrials.gov/ct2/show/NCT02142868

Key Eligibility Criteria Details

Post menopausal woman (defined by local guidelines or clinical practice)
ER+ or PR+ (local lab OK)
HER2 negative(local lab OK)
Appropriate candidates for letrozole
ECOG PS 0-2
ANC>1.5, plt>100, Hgb>9
ALT/AST <5x ULN
Tbili <3x ULN
Cr <1.5 ULN or GFR >60
No prior tx with CDK4/6 inhibitor
No high cardiovascular risk (recent MI, long QT, arrythmias)
No other malignancy within 3 years
No uncontrolled brain mets

Objective

Primary: Expanded access Secondary: Additional safety and efficacy data

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER or PR positive HER2 negative

Dosing Frequency

Palbociclib 125mg PO qday x21 days then off 7 days. Letrozole 2.5mg PO qday

Control Agents

N/A

Study Protocol

Randomized