West Cancer Center

BREAST; Neoadjuvant; ER/PR+; "MONALEESA-1"

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer__

Title

Novartis CLEE011A2201

Study Title

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer__

Site Link

NCT01919229

Malignancy

Breast Cancer, Early Breast Cancer

Stage

Stage 1

Disease Setting

Neoadjuvant

Line Of Therapy

N/A

Investigational Agent

LEE011

Drug Class

CDK 4/6 Inhibitor

Lee Schwartzberg, MD

Sponsor

Novartis

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Clinicaltrials.gov

Key Eligibility Criteria Details

Resectable breast cancer
Postmenopausal
ER and/or PR positive (+)
Grade 2 (II) or 3 (III) invasive cancer
HER2 - (negative)
One lesion at least 1.0 cm by imaging
ECOG 0 or 1
No prior therapy
No active cardiac history, QT prolongation
No strong concurrent CYP3A4 inducers/inhibitors

Objective

Primary: Cell cycle response rate (Ki-67<1 at time of surgery). Secondary: Safety and tolerability; PK; ECG changes; CDK expression changes

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER+ or PR+ (positive) HER2 - (negative)Grade 2 or 3 invasive disease

Dosing Frequency

Control Agents

Letrozole

Study Protocol

Randomized

Yes