ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

ClinicalTrials.gov ID: NCT03701334

Public ClinicalTrials.gov record NCT03701334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Study identification

NCT ID
NCT03701334
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
5,101 participants

Conditions and interventions

Interventions

  • Endocrine Therapy (ET) Other
  • Ribociclib Drug

Other · Drug

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 6, 2018
Primary completion
May 28, 2030
Completion
May 28, 2030
Last update posted
Mar 31, 2026

2018 – 2030

United States locations

U.S. sites
73
U.S. states
31
U.S. cities
71
Facility City State ZIP Site status
University of Alabama at Birmingham-Kirklin Clinic Birmingham Alabama 35294-0006
Cancer Treatment Centers of America Goodyear Arizona 85338
St Bernards Medical Center Jonesboro Arkansas 72401
Comprehensive Blood and Cancer Bakersfield California 93309
UCLA Beverly Hills Beverly Hills California 90212
UCLA Burbank Burbank California 91505
Encino Research Center Encino California 91436
St. Jude Heritage Medical Group Fullerton California 92835
UCLA Hematology Oncology Laguna Hills California 92653
Southern CA Oncology Rsrch Alliance Los Angeles California 90057
Stanford University Medical Center Palo Alto California 94304-1509
UCLA Pasadena HC Hemato Onco Pasadena California 941105
UCLA Porter Ranch Hemato and Onco Porter Ranch California 91326
Cancer Care Associates Medical Grp Redondo Beach California 90277
Sharp Memorial Hospital San Diego California 92123
UCSF San Francisco California 94115
Central Coast Medical Oncology Corporation Santa Maria California 93454
UCLA Santa Monica Hematology Oncology Santa Monica California 90404
Lundquist Inst BioMed at Harbor Torrance California 90509-2910
UCLA Valencia Valencia California 91355
Valley Breast Care Van Nuys California 91405
UCLA Cancer Center Westlake Village Westlake Village California 91361
University Of Colorado Hospital Aurora Colorado 80045
Rocky Mountain Cancer Centers Denver Colorado 80218
Hospital of Central Connecticut New Britain Connecticut 06052
Yale University School Of Medicine New Haven Connecticut 06520
Norwalk Hospital Norwalk Connecticut 06856
Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut 06360
Holy Cross Hospital-Ft. Lauderdale Fort Lauderdale Florida 33308
Florida Cancer Specialists Fort Myers Florida 33901
Memorial Cancer Institute Hollywood Florida 33021
Baptist MD Anderson Cancer Center Jacksonville Florida 32207
University of Miami Miami Florida 33136
Orlando Health Clinical Trials Orlando Florida 32806
Florida Cancer Specialists-North St. Petersburg Florida 33705
Florida Cancer Specialists Pan Tallahassee Florida 32308
Florida Cancer Specialists West Palm Beach Florida 33401
Winship Cancer Institute of Emory University Atlanta Georgia 30322
Southeastern Regional Medical Center Newnan Georgia 30265
Cancer Treatment Centers of America Zion Illinois 60099
Cancer Care Center New Albany Indiana 47150
University of Kansas Cancer Center Westwood Kansas 66205
Cancer Center of Kansas Wichita Kansas 67214-3728
Norton Cancer Institute Louisville Kentucky 40202
Mercy Medical Center Baltimore Maryland 21202
Massachusetts General Hospital Boston Massachusetts 02114
University of Michigan Cancer Center Ann Arbor Michigan 48109
Fairview Health Services Maple Grove Minnesota 55369
Metro Minnesota CCOP Saint Louis Park Minnesota 55416
Park Nicollet Institute Saint Louis Park Minnesota 55416
Saint Lukes Hospital of Kansas City Kansas City Missouri 64111
HCA Midwest Division Kansas City Missouri 64132
David C Pratt Cancer Center St Louis Missouri 63141
St Vincent Frontier Cancer Center Billings Montana 59102
Saint Francis Medical Center Grand Island Nebraska 68803
Comprehensive Cancer Cntr Of Nevada Henderson Nevada 89052
Saint Barnabas Medical Center Livingston New Jersey 07039
Perlmutter Cancer Centre New York New York 10016
Randolph Medical Associates Asheboro North Carolina 27204
Cone Health Cancer Center Greensboro North Carolina 27403
Kaiser Permanente NW Region Clackamas Oregon 97015
Penn State Hershey Cancer Institute Hershey Pennsylvania 17033
Cancer Treatment Centers of America Eastern Regional Medical Center Philadelphia Pennsylvania 19124
The West Clinic Germantown Tennessee 38138
Sarah Cannon Research Institute Nashville Tennessee 37203
Baylor Charles A Sammons Cancer Cnt Dallas Texas 75246
Ctr For Cancer And Blood Disorders Fort Worth Texas 76104
MD Anderson Cancer Center University of Texas Houston Texas 77030
Utah Cancer Specialists Salt Lake City Utah 84106
Virginia Cancer Specialists Fairfax Virginia 22031
Virginia Cancer Institute Richmond Virginia 23230
Fred Hutchinson Cancer Center Seattle Washington 98109
University of Wisconsin Paul P Carbone Comp Cancer Center Madison Wisconsin 53792 6164

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 314 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03701334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 31, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03701334 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →