West Cancer Center

BREAST: ADJUVANT: ER/PR+: CDK4/6: NATALEE

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE

Title

Novartis CLEE011O12301C: NATALEE Breast

Study Title

Site Link

NCT03701334

Malignancy

Breast cancer, Invasive breast cancer, BC

Stage

Stage 2

Disease Setting

Adjuvant/Curative

Line Of Therapy

Aduvant

Investigational Agent

Ribociclib

Drug Class

CDK4/6 inhibitor

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed unilateral adenocarcinoma of the breast
Positive for ER and/or PgR
HER2 negative
Patient has had surgical resection where tumor was removed completely with negative margins
Anatomic Stage II or III
Completed neoadjuvant or adjuvant chemotherapy (if indicated)
Completed adjuvant XRT (if indicated)
Plan to treat pt with endocrine tx for 5 years
No prior CDK4/6 inhibitor
No prior tamoxifen, ralixofene, or AIs for chemoprevention
No prior tx with anthracycline at cumulative doses of 450mg/m2 or more
No distant metastatic disease
No other cancer within 2 years of study enrollment
No known HIV/HBV/HCV
No clinically significant cardiac disease

Objective

Primary: Invasive Disease Free Survival (IIDFS)
Secondary: RFS, distant DFS, OS, QOL, safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER or PR positive (HR+), adenocarcinoma

Dosing Frequency

Control Agents

endocrine therapy

Study Protocol

Randomized

Yes