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Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Official title: A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1466
Start Date
2024-02-28
Completion Date
2030-09-20
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Letrozole
Letrozole 2.5 mg orally once daily continuously
Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Goserelin
Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used
Leuprolide
Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used
Exemestane
Exemestane 25 mg once daily continuously
Locations (214)
Central Alabama Research
Birmingham, Alabama, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Western Reg MC-COH Phoenix
Goodyear, Arizona, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Onco Inst of Hope and Innovation
Cerritos, California, United States
City of Hope National Medical
Duarte, California, United States
Providence Medical Foundation
Fullerton, California, United States
Los Angeles Cancer Network Good Samaritan
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Palo Alto Medical Foundation
Mountain View, California, United States
UC Irvine Medical Center
Orange, California, United States
Sutter Inst Medical Research
Sacramento, California, United States
School Of Medicine
Sacramento, California, United States
Sharp Rees Stealy Medical Group Inc
San Diego, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States
Holy Cross Health
Fort Lauderdale, Florida, United States
Hialeah Hospital
Hialeah, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Ocala Research Institute Inc
Ocala, Florida, United States
Summit Cancer Care PC
Savannah, Georgia, United States
Affiliated Oncologists IL
Chicago, Illinois, United States
Hope And Healing Care
Hinsdale, Illinois, United States
Midwestern Reg MC COH Chicago
Zion, Illinois, United States
Investigative Clinical R of Indiana
Indianapolis, Indiana, United States
University of Iowa Health Care
Waukee, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, United States
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota, United States
Jackson Oncology Associates
Jackson, Mississippi, United States
HCA Midwest Division
Kansas City, Missouri, United States
WA Uni School Of Med
St Louis, Missouri, United States
Intermountain Healthcare
Billings, Montana, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Cancer Care Specialists
Reno, Nevada, United States
MD Anderson Cancer Center At Cooper
Camden, New Jersey, United States
Summit Health
Florham Park, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Presbyterian Medical Group
Albuquerque, New Mexico, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Optum Health
Lake Success, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Duke Cancer Network
Durham, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Sanford Research USD Fargo
Fargo, North Dakota, United States
Good Samaritan Regional Medical Center
Corvallis, Oregon, United States
Oncology Associates of Oregon PC
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Oregon Oncology Specialists Salem
Salem, Oregon, United States
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania, United States
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Bon Secours St Francis Cancer Center
Greenville, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
El Paso Texas Oncology
El Paso, Texas, United States
Kelsey Seybold Clinic
Houston, Texas, United States
University of Texas
Houston, Texas, United States
Texas Oncology P A Plano East
Plano, Texas, United States
Texas Oncology PA Tyler
Tyler, Texas, United States
Bon Secours Virginia Health System
Midlothian, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Kadlec Clinic Hematology and Onco
Kennewick, Washington, United States
Providence Regional Cancer System
Lacey, Washington, United States
Valley Medical Center Research
Renton, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Novartis Investigative Site
Córdoba, Argentina
Novartis Investigative Site
Gateshead, New South Wales, Australia
Novartis Investigative Site
Tiwi, Northern Territory, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
Rio de Janeiro, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Victoria, British Columbia, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Oakville, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada