Recruiting
Phase 3

Ribociclib & ET

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

Study Details

Brief 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).

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Key Inclusion criteria:

  • Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).
  • Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.
  • Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.
  • Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
  • For participants with prior ET treatment > 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.
  • The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
  • Participant has no contraindication to receive adjuvant ET in the study.
  • Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:

  • Anatomic Stage Group III, or
  • Anatomic Stage Group IIB, or
  • A subset of Anatomic Stage Group IIA.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
  • Participant has adequate bone marrow and organ function.
  • ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:

  • QTcF interval at Screening < 450 msec (QT interval using Fridericia's correction).
  • Mean resting heart rate 50-99 beats per minute (determined from the ECG).

Key Exclusion criteria:

  • Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
  • Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
  • Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
  • Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
  • Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.

Other inclusion/exclusion criteria may apply

Study Design

Enrollment

1400 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ribociclib + endocrine therapy

Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of:

  • For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously.
  • For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin 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) or leuprolide 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)

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

Primary outcome measure

  • Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years [ Time Frame: At 3 years ]

Central Contacts and Locations

Central contacts

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Principal 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

Principal 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

Principal Investigator:

Mili Arora

Sharp Rees Stealy Medical Group Inc

Recruiting

San Diego, California, United States, 92101

Contacts

Principal Investigator:

Kenneth Johnson

AdventHealth Medical Group Hematology and Oncology

Recruiting

Denver, Colorado, United States, 80210

Contacts

Principal 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

Principal 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

Principal Investigator:

Luis G Rangel

Memorial Cancer Institute

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Florencia Brunengo

fbrunengo@mhs.net

Principal 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.com

Principal Investigator:

Amanda Hathaway

Summit Cancer Care PC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Principal Investigator:

Mark A Taylor

Hawaii Cancer Care

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Principal Investigator:

Arnold K N Yee

Affiliated Oncologists IL

Recruiting

Chicago, Illinois, United States, 60415

Contacts

Principal Investigator:

Rami Haddad

Hope And Healing Care

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Keerthana Kolluri

kkolluri@hopenheal.care

Principal 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

Principal Investigator:

Ruemu Birhiray

University of Iowa Health Care

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Principal Investigator:

Seema Harichand-Herdt

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Chasity Cupp

ccupp@kumc.edu

Principal 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.com

Principal 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

Principal Investigator:

Carol Tweed

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Tara Hassani Goodarzi

tara.hassanigoodarzi@bmc.org

Principal 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

Principal 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

Principal 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

Principal 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

Principal Investigator:

Lee Schwartzberg

Cancer Care Specialists

Recruiting

Reno, Nevada, United States, 89511

Contacts

Layla Quinonez

Lquinonez@ccsreno.com

Principal Investigator:

Sowjanya Reganti

MD Anderson Cancer Center At Cooper

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Principal 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

Principal 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.edu

Principal Investigator:

Melanie Kier

Duke Cancer Network

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal 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

Principal 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

Principal Investigator:

Janelle Meyer

Consultants In Med Onco And Hema

Recruiting

Drexel Hill, Pennsylvania, United States, 19026

Contacts

Principal 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

Principal 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

Principal 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

Principal 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.com

Principal 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

Principal 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

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Hormone receptor positive (HR+)
  • Human epidermal growth factor receptor-2 negative (HER2-)
  • Early breast cancer (EBC)
  • premenopausal
  • postmenopausal
  • male breast cancer
  • ribociclib
  • LEE011
  • Endocrine therapy (ET)

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.