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)
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).
Detailed description
The study consists of Screening, Treatment, and Follow-up periods. * Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment. * Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study \[EOS\]), whichever occurs first.
Arms & interventions
- DrugRibociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
- DrugLetrozole
Letrozole 2.5 mg orally once daily continuously
- DrugAnsastrozole
Anastrozole 1 mg orally once daily continuously.
- DrugGoserelin
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
- DrugLeuprolide
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
- DrugExemestane
Exemestane 25 mg once daily continuously
Outcome measures
Primary
Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. The iBCFS rate at 3 years will be assessed.
Time frame: At 3 years
Secondary
Incidence and severity of adverse events (AEs) using CTCAE v4.03
Time frame: Up to approximately 6 years
Invasive Disease-Free Survival (iDFS)
Time frame: Up to approximately 6 years
Distant Disease-Free Survival (DDFS)
Time frame: Up to approximately 6 years
Distant Relapse-Free Survival (DRFS)
Time frame: Up to approximately 6 years
Recurrence-Free Interval (RFI)
Time frame: Up to approximately 6 years
Relative dose intensity (RDI) of ribociclib
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to approximately 6 years
Time To Discontinuation (TTD) of ribociclib
Time frame: Up to 3 years
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
Time frame: Up to approximately 6 years
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
Time frame: Up to approximately 6 years
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
Time frame: Up to approximately 6 years
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
Time frame: Up to approximately 6 years
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
Time frame: Up to approximately 6 years
Eligibility criteria
Study locations (78)
Central Alabama Research
Birmingham, Alabama, 35209
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
Western Reg MC-COH Phoenix
Goodyear, Arizona, 85338
CARTI Cancer Center
Little Rock, Arkansas, 72205
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Onco Inst of Hope and Innovation
Cerritos, California, 90703
City of Hope National Medical
Duarte, California, 91010
Providence Medical Foundation
Fullerton, California, 92835
Palo Alto Medical Foundation
Mountain View, California, 94040
UC Irvine Medical Center
Orange, California, 92868
Sutter Inst Medical Research
Sacramento, California, 95816-5199
School Of Medicine
Sacramento, California, 95817
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197
Washington Hospital Center
Washington D.C., District of Columbia, 20010
AdventHealth Altamonte Springs
Altamonte Springs, Florida, 32701
Holy Cross Health
Fort Lauderdale, Florida, 33308
Hialeah Hospital
Hialeah, Florida, 33013
Memorial Cancer Institute
Hollywood, Florida, 33021
Jupiter Medical Center
Jupiter, Florida, 33458
Ocala Research Institute, Inc
Ocala, Florida, 34474
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Summit Cancer Care PC
Savannah, Georgia, 31405
Hawaii Cancer Care
Honolulu, Hawaii, 96813
Affiliated Oncologists IL
Chicago, Illinois, 60415
Hope And Healing Care
Hinsdale, Illinois, 60521
Midwestern Reg MC COH Chicago
Zion, Illinois, 60099
Investigative Clinical R of Indiana
Indianapolis, Indiana, 46260
University of Iowa Health Care
Waukee, Iowa, 50263
University of Kansas Cancer Center
Westwood, Kansas, 66205
Cancer Center of Kansas
Wichita, Kansas, 67214-3728
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103
Mercy Medical Center
Baltimore, Maryland, 21202
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
Boston Medical Center
Boston, Massachusetts, 02118
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Dana Farber Brigham Women Cancer
Milford, Massachusetts, 01757
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, 55404
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota, 55407
Jackson Oncology Associates
Jackson, Mississippi, 39202
HCA Midwest Division
Kansas City, Missouri, 64132
WA Uni School Of Med
St Louis, Missouri, 63110
Intermountain Healthcare
Billings, Montana, 59102
Nebraska Cancer Specialists
Omaha, Nebraska, 68154
Renown Regional Medical Center
Reno, Nevada, 89502
Cancer Care Specialists
Reno, Nevada, 89511
Summit Health
Florham Park, New Jersey, 07932
The Valley Hospital
Ridgewood, New Jersey, 07450
Presbyterian Medical Group
Albuquerque, New Mexico, 87110
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Optum Health
Lake Success, New York, 11042
Mount Sinai School of Medicine
New York, New York, 10029
Duke Cancer Network
Durham, North Carolina, 27710
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Sanford Research USD Fargo
Fargo, North Dakota, 58122
Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330
Oncology Associates of Oregon PC
Eugene, Oregon, 97401-8122
Northwest Cancer Specialists
Portland, Oregon, 97210
Oregon Oncology Specialists Salem
Salem, Oregon, 97301
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania, 19026
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania, 17109
Rhode Island Hospital
Providence, Rhode Island, 02903
Bon Secours St Francis Cancer Center
Greenville, South Carolina, 29607
Lexington Medical Center
West Columbia, South Carolina, 29169
Regional Medical Oncology NC
Wilson, South Carolina, 27893
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
El Paso Texas Oncology
El Paso, Texas, 79902
Kelsey Seybold Clinic
Houston, Texas, 77025
University of Texas
Houston, Texas, 77030-4099
Texas Oncology P A Plano East
Plano, Texas, 75075
Texas Oncology PA Tyler
Tyler, Texas, 75702
Bon Secours Virginia Health System
Midlothian, Virginia, 23114
Virginia Oncology Associates
Norfolk, Virginia, 23502
Kadlec Clinic Hematology and Onco
Kennewick, Washington, 99336
Providence Regional Cancer System
Lacey, Washington, 98503
Valley Medical Center Research
Renton, Washington, 98055
Northwest Medical Specialties
Tacoma, Washington, 98405