Sponsor:
Novartis Pharmaceuticals
Code:
NCT05827081
Conditions
Early Breast Cancer
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Interventions
Ribociclib
Letrozole
Ansastrozole
Goserelin
Leuprolide
Brief summary:
Conditions
Early Breast Cancer
Study ID
NCT05827081
Start date
Feb 28, 2024
Status verified date
Sep, 2026
Completion date
Sep 20, 2030
Anticipated
Primary completion date
Sep 7, 2029
Anticipated
Eligibility Criteria
Sex: All
Age: 18 - 70+
Healthy Volunteers: Not accepted
Enrollment
1400 participants
Anticipated
Intervention Model
Single group
Primary purpose
Treatment
Arms
experimental: Ribociclib + endocrine therapy
Interventions
Ribociclib
Letrozole
Ansastrozole
Goserelin
Leuprolide
Exemestane
Primary outcome measure
Central contacts
Locations
Central Alabama Research
Recruiting
Birmingham, Alabama, United States, 35209
Contacts
Lorie Szymela
LSzymela@centralalabamaresearch.comPrincipal Investigator:
David Mooney
Alaska Oncology and Hematology LLC
Recruiting
Anchorage, Alaska, United States, 99508
Contacts
Principal Investigator:
Steven Liu
Western Reg MC-COH Phoenix
Recruiting
Goodyear, Arizona, United States, 85338
Contacts
Principal Investigator:
Cynthia Lynch
CARTI Cancer Center
Recruiting
Little Rock, Arkansas, United States, 72205
Contacts
Principal Investigator:
Issam Sam Makhoul
Beverly Hills Cancer Center
Recruiting
Beverly Hills, California, United States, 90211
Contacts
Principal Investigator:
Linnea Chap
Onco Inst of Hope and Innovation
Recruiting
Cerritos, California, United States, 90703
Contacts
Principal Investigator:
Pamela Miel
City of Hope National Medical
Recruiting
Duarte, California, United States, 91010
Contacts
Principal Investigator:
Thanh Nga Doan
Providence Medical Foundation
Recruiting
Fullerton, California, United States, 92835
Contacts
Principal Investigator:
Giribala R Patel
Los Angeles Cancer Network Good Samaritan
Recruiting
Los Angeles, California, United States, 90017
Contacts
Principal Investigator:
Lasika Chandradatta Seneviratne
El Camino Hospital
Recruiting
Mountain View, California, United States, 94040
Contacts
Zoe Higgins
zoe_higgins@elcaminohealth.orgPrincipal Investigator:
Priya Jayachandran
Palo Alto Medical Foundation
Recruiting
Mountain View, California, United States, 94040
Contacts
Principal Investigator:
Natalia Colocci
UC Irvine Medical Center
Recruiting
Orange, California, United States, 92868
Contacts
Principal Investigator:
Ritesh Parajuli
Sutter Inst Medical Research
Recruiting
Sacramento, California, United States, 95816-5199
Contacts
Principal Investigator:
Nitin Rohatgi
School Of Medicine
Recruiting
Sacramento, California, United States, 95817
Contacts
Apinya Vorasaph
avorasaph@health.ucdavis.eduPrincipal Investigator:
Mili Arora
Sharp Rees Stealy Medical Group Inc
Recruiting
San Diego, California, United States, 92101
Contacts
Danica Griffin
danica.griffin@sharp.comPrincipal Investigator:
Kenneth Johnson
AdventHealth Medical Group Hematology and Oncology
Recruiting
Denver, Colorado, United States, 80210
Contacts
Melanie Burland
Melanie.Burland@adventhealth.comPrincipal Investigator:
Nadine G Mikhaeel Kamel
Rocky Mountain Cancer Centers
Recruiting
Denver, Colorado, United States, 80218
Contacts
Principal Investigator:
Mabel Mardones
Georgetown University Lombardi Cancer Center
Recruiting
Washington D.C., District of Columbia, United States, 20007-2197
Contacts
Principal Investigator:
Katia Khoury
Medstar Washington Hospital Center
Recruiting
Washington D.C., District of Columbia, United States, 20010
Contacts
Principal Investigator:
Ami Chitalia
AdventHealth Altamonte Springs
Recruiting
Altamonte Springs, Florida, United States, 32701
Contacts
Rebecca Iorio
rebecca.iorio@adventhealth.comPrincipal Investigator:
Wassim Mchayleh
Holy Cross Health
Recruiting
Fort Lauderdale, Florida, United States, 33308
Contacts
Principal Investigator:
Karim Arnaout
Hialeah Hospital
Recruiting
Hialeah, Florida, United States, 33013
Contacts
Yolanda Batista
ybatista@bioresearchpartner.comPrincipal Investigator:
Luis G Rangel
Memorial Cancer Institute
Recruiting
Hollywood, Florida, United States, 33021
Contacts
Florencia Brunengo
fbrunengo@mhs.netPrincipal Investigator:
Adriana Milillo Naraine
Jupiter Medical Center
Recruiting
Jupiter, Florida, United States, 33458
Contacts
Principal Investigator:
Danielle Krol
Ocala Research Institute, Inc
Recruiting
Ocala, Florida, United States, 34474
Contacts
Principal Investigator:
Anju Vasudevan
University Cancer and Blood Center LLC
Recruiting
Athens, Georgia, United States, 30607
Contacts
Christen Nicole Cooper Pope
npope@universitycancer.comPrincipal Investigator:
Amanda Hathaway
Summit Cancer Care PC
Recruiting
Savannah, Georgia, United States, 31405
Contacts
Theresa Williams
twilliams@summitcancercare.comPrincipal Investigator:
Mark A Taylor
Hawaii Cancer Care
Recruiting
Honolulu, Hawaii, United States, 96813
Contacts
Angelei Gommesen
AngeleiJan.Gommesen@aoncology.comPrincipal Investigator:
Arnold K N Yee
Affiliated Oncologists IL
Recruiting
Chicago, Illinois, United States, 60415
Contacts
Angela Malone
angela.malone@usoncology.comPrincipal Investigator:
Rami Haddad
Hope And Healing Care
Recruiting
Hinsdale, Illinois, United States, 60521
Contacts
Keerthana Kolluri
kkolluri@hopenheal.carePrincipal Investigator:
Srilata Gundala
Midwestern Reg MC COH Chicago
Recruiting
Zion, Illinois, United States, 60099
Contacts
Principal Investigator:
Ajaz Khan
Investigative Clinical R of Indiana
Recruiting
Indianapolis, Indiana, United States, 46260
Contacts
Zara Edgell
zedgell@investigativeicr.comPrincipal Investigator:
Ruemu Birhiray
University of Iowa Health Care
Recruiting
Waukee, Iowa, United States, 50263
Contacts
Theresa Caon
tcaon@missioncancer.comPrincipal Investigator:
Seema Harichand-Herdt
University of Kansas Cancer Center
Recruiting
Westwood, Kansas, United States, 66205
Contacts
Chasity Cupp
ccupp@kumc.eduPrincipal Investigator:
Priyanka Sharma
Cancer Center of Kansas
Recruiting
Wichita, Kansas, United States, 67214-3728
Contacts
Principal Investigator:
Shaker R Dakhil
Willis-Knighton Cancer Center
Recruiting
Shreveport, Louisiana, United States, 71103
Contacts
Briana Barrow
bbarrow@wkhs.comPrincipal Investigator:
Prakash Peddi
Mercy Medical Center
Recruiting
Baltimore, Maryland, United States, 21202
Contacts
Principal Investigator:
David Andrew Riseberg
Maryland Oncology Hematology P A
Recruiting
Silver Spring, Maryland, United States, 20904
Contacts
Teresa Saavedra
teresa.saavedra@usoncology.comPrincipal Investigator:
Carol Tweed
Boston Medical Center
Recruiting
Boston, Massachusetts, United States, 02118
Contacts
Tara Hassani Goodarzi
tara.hassanigoodarzi@bmc.orgPrincipal Investigator:
Jose J Acevedo
Dana Farber Cancer Institute
Recruiting
Boston, Massachusetts, United States, 02215
Contacts
Principal Investigator:
Erica Mayer
Dana Farber Brigham Women Cancer
Recruiting
Milford, Massachusetts, United States, 01757
Contacts
Principal Investigator:
Natalie Sinclair
Minnesota Oncology Hematology P A
Recruiting
Minneapolis, Minnesota, United States, 55404
Contacts
Anne Rabenn
Anne.rabenn@usoncology.comPrincipal Investigator:
Eric Lander
Allina Hlth Cancer Inst Minneapolis
Recruiting
Minneapolis, Minnesota, United States, 55407
Contacts
Principal Investigator:
Daniel Carlson
Jackson Oncology Associates
Recruiting
Jackson, Mississippi, United States, 39202
Contacts
Principal Investigator:
Justin T Baker
HCA Midwest Division
Recruiting
Kansas City, Missouri, United States, 64132
Contacts
Katie Burnside
katherine.burnside@hcahealthcare.comPrincipal Investigator:
Anis Toumeh
WA Uni School Of Med
Recruiting
St Louis, Missouri, United States, 63110
Contacts
Principal Investigator:
Katherine Clifton
Intermountain Healthcare
Recruiting
Billings, Montana, United States, 59102
Contacts
Kelsi Margaris
kelsi.margaris@imail.orgPrincipal Investigator:
Patrick Cobb
Nebraska Cancer Specialists
Recruiting
Omaha, Nebraska, United States, 68154
Contacts
Principal Investigator:
Margaret Barbara Block
Renown Regional Medical Center
Recruiting
Reno, Nevada, United States, 89502
Contacts
Bayley Stoner
Bayley.Stoner@renown.orgPrincipal Investigator:
Lee Schwartzberg
Cancer Care Specialists
Recruiting
Reno, Nevada, United States, 89511
Contacts
Layla Quinonez
Lquinonez@ccsreno.comPrincipal Investigator:
Sowjanya Reganti
MD Anderson Cancer Center At Cooper
Recruiting
Camden, New Jersey, United States, 08103
Contacts
Naimik Patel
patel-naimik@cooperhealth.eduPrincipal Investigator:
Ahmed Kamel Abou Hussein
Summit Health
Recruiting
Florham Park, New Jersey, United States, 07932
Contacts
Principal Investigator:
Steven Papish
The Valley Hospital
Recruiting
Ridgewood, New Jersey, United States, 07450
Contacts
Emily Clark
eclark2@valleyhealth.comPrincipal Investigator:
Amanda Podolski
Presbyterian Medical Group
Recruiting
Albuquerque, New Mexico, United States, 87110
Contacts
Principal Investigator:
Yashvin Onkarappa Mangala
Queens Cancer Center of Queens Hospital
Recruiting
Jamaica, New York, United States, 11432
Contacts
Principal Investigator:
Ellen Hagopian
Optum Health
Recruiting
Lake Success, New York, United States, 11042
Contacts
Principal Investigator:
Jonathan Goldberg
Mount Sinai School of Medicine
Recruiting
New York, New York, United States, 10029
Contacts
Weronika Bucwinska
weronika.bucwinska@mssm.eduPrincipal Investigator:
Melanie Kier
Duke Cancer Network
Recruiting
Durham, North Carolina, United States, 27710
Contacts
Catrin Davies
catrin.davies@duke.eduPrincipal Investigator:
Madhu Chaudhry
Cone Health Cancer Center
Recruiting
Greensboro, North Carolina, United States, 27403
Contacts
Principal Investigator:
Vinay Gudena
Sanford Research USD Fargo
Recruiting
Fargo, North Dakota, United States, 58122
Contacts
Principal Investigator:
Anu Goel Gaba
Good Samaritan Regional Medical Center
Recruiting
Corvallis, Oregon, United States, 97330
Contacts
Principal Investigator:
John Strother
Oncology Associates of Oregon PC
Recruiting
Eugene, Oregon, United States, 97401-8122
Contacts
Spencer Dandy
Spencer.dandy@usoncology.comPrincipal Investigator:
Miho Dougherty
Northwest Cancer Specialists
Recruiting
Portland, Oregon, United States, 97210
Contacts
Principal Investigator:
Jay Andersen
Oregon Oncology Specialists Salem
Recruiting
Salem, Oregon, United States, 97301
Contacts
Kyla Kinney
kkinney@orcancer.comPrincipal Investigator:
Janelle Meyer
Consultants In Med Onco And Hema
Recruiting
Drexel Hill, Pennsylvania, United States, 19026
Contacts
Maureen Lisowski
maureen.Lisowski@usoncology.comPrincipal Investigator:
Alexander Deak
Univ of Pittsburg Med Ctr Pinnacle
Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contacts
Principal Investigator:
Marija Balic
Allegheny Health Network
Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contacts
Sarah Montini
sarah.montini@ahn.orgPrincipal Investigator:
Joseph Liput
Rhode Island Hospital
Recruiting
Providence, Rhode Island, United States, 02903
Contacts
Principal Investigator:
Stephanie Graff
Bon Secours St Francis Cancer Center
Recruiting
Greenville, South Carolina, United States, 29607
Contacts
Principal Investigator:
Stephen Howard Dyar
Sanford USD Medical Center
Recruiting
Sioux Falls, South Dakota, United States, 57104
Contacts
Principal Investigator:
Allison Watson
Sarah Cannon Research Institute
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Principal Investigator:
Denise A Yardley
El Paso Texas Oncology
Recruiting
El Paso, Texas, United States, 79902
Contacts
Mary Williams
mary.williams2@usoncology.comPrincipal Investigator:
Ines Sanchez-Rivera
Kelsey Seybold Clinic
Recruiting
Houston, Texas, United States, 77025
Contacts
Principal Investigator:
Sunil Patel
University of Texas
Recruiting
Houston, Texas, United States, 77030-4099
Contacts
Principal Investigator:
Jason Mouabbi
Texas Oncology P A Plano East
Recruiting
Plano, Texas, United States, 75075
Contacts
Principal Investigator:
Carlos Taboada
Texas Oncology PA Tyler
Recruiting
Tyler, Texas, United States, 75702
Contacts
Jennifer Castner
jennifer.castner@usoncology.comPrincipal Investigator:
Sasha Davis
Bon Secours Virginia Health System
Recruiting
Midlothian, Virginia, United States, 23114
Contacts
Principal Investigator:
William Irvin
Virginia Oncology Associates
Recruiting
Norfolk, Virginia, United States, 23502
Contacts
Patricia Innis-Deleon
patricia.deleon@usoncology.comPrincipal Investigator:
Michael A Danso
Kadlec Clinic Hematology and Onco
Recruiting
Kennewick, Washington, United States, 99336
Contacts
Principal Investigator:
Ying Zhuo
Providence Regional Cancer System
Recruiting
Lacey, Washington, United States, 98503
Contacts
Principal Investigator:
Mijung Lee
Valley Medical Center Research
Recruiting
Renton, Washington, United States, 98055
Contacts
Dione Froman
Dione_Froman@valleymed.orgPrincipal Investigator:
Navanshu Arora
Northwest Medical Specialties
Recruiting
Tacoma, Washington, United States, 98405
Contacts
Principal Investigator:
Sibel Blau
Medical College of Wisconsin
Recruiting
Milwaukee, Wisconsin, United States, 53226
Contacts
Principal Investigator:
Lubna Chaudhary
Novartis Investigative Site
Recruiting
Toronto, Ontario, Canada, M4N 3M5
Novartis Investigative Site
Recruiting
Toronto, Ontario, Canada, M5T 3L9
Novartis Investigative Site
Recruiting
Montreal, Quebec, Canada, H3T 1E2
Novartis Investigative Site
Recruiting
Montreal, Quebec, Canada, H4A 3J1
Novartis Investigative Site
Recruiting
Québec, Quebec, Canada, G1S 4L8
Novartis Investigative Site
Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsor
Novartis Pharmaceuticals
Last update posted
Sep 4, 2026
Last verified
Sep, 2026
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-09-04.