54
Participants
Start Date
June 20, 2017
Primary Completion Date
March 9, 2020
Study Completion Date
March 9, 2020
Ribociclib
"Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).~Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth."
Adjuvant endocrine therapy
Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days.
Placebo
"Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).~Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth."
Pro Health Care Associates, New Hyde Park
Maryland Oncology Hematology P A, Silver Spring
Fairfax Northern Virginia Hem/Onc, Fairfax
The Presbyterian Hospital, Charlotte
Northside Hospital Central Research Dept., Atlanta
Summit Cancer Care, PC, Savannah
Memorial Regional Hospital, Hollywood
Florida Cancer Specialists - North Florida Cancer Specialist N, St. Petersburg
Florida Cancer Specialists South Region, Fort Myers
Hematology Oncology Associates of the Treasure Coast, Port Saint Lucie
SCRI - Tennessee Oncology, Nashville
Tennessee Oncology, PLLC, Chattanooga
The West Clinic, Germantown
Saint Luke's Hospital of Kansas City, Kansas City
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Div., Leawood
Highlands Oncology Group, Fayetteville
Baylor Charles A. Sammons Cancer Center, Dallas
Texas Oncology P A Texas Oncology - Houston, Dallas
Texas Oncology PA - Tyler, Tyler
Millennium Oncology, Houston
Cancer Care Network of South Texas, San Antonio
Rocky Mountain Cancer Centers Regulatory, Denver
Arizona Oncology Associates PC- HAL, Tucson
University of California - Los Angeles, Los Angeles
TRIO - Torrance Health Association, Redondo Beach
Innovative Clinical Research Institute, Whittier
Ventura County Hematology and Oncology, Oxnard
CBCC Global Research, Bakersfield
Multicare Institute for Research and Innovation, Tacoma
Northwest Medical Specialties, Tacoma
Wenatchee Valley Hospital and Clinics, Wenatchee
Eastern Connecticut Hematology and Oncology Associates, Norwich
Saint Barnabas Medical Center 2nd Floor East Wing, Livingston
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY