Recruiting

Phase 3

Ribociclib & ETPhase IIIb Study of Ribociclib + ET in Early Breast Cancer

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

Oct, 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

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

1444 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

Novartis Pharmaceuticals

1-888-669-6682 novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Lorie Szymela

LSzymela@centralalabamaresearch.com

Principal Investigator:

David Mooney

Alaska Oncology and Hematology LLC

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Talia Wyckoff

907-279-3155 talia@alaskaoncology.com

Principal Investigator:

Steven Liu

Onco Inst of Hope and Innovation

Recruiting

Cerritos, California, United States, 90703

Contacts

Sabrina Mora

562-698-6888 sabrina.mora@heliosclinical.com

Principal Investigator:

Pamela Miel

City of Hope National Medical

Recruiting

Duarte, California, United States, 91010

Contacts

Felicia Lewis

+1 6263598111#65994 flewis@coh.org

Principal Investigator:

Thanh Nga Doan

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Contacts

Teresa Olea

714-449-6200 teresa.olea@stjoe.org

Principal Investigator:

Giribala R Patel

Los Angeles Cancer Network Good Samaritan

Recruiting

Los Angeles, California, United States, 90017

Contacts

Tannya Lovato

213-977-1214 tannya.lovato@lahomg.com

Principal Investigator:

Lasika Chandradatta Seneviratne

El Camino Hospital

Recruiting

Mountain View, California, United States, 94040

Contacts

Zoe Higgins

zoe_higgins@elcaminohealth.org

Principal Investigator:

Priya Jayachandran

Palo Alto Medical Foundation

Recruiting

Mountain View, California, United States, 94040

Contacts

Christine Lee

650-853-5763 christine.lee4@sutterhealth.org

Principal Investigator:

Natalia Colocci

Sharp Rees Stealy Medical Group Inc

Recruiting

San Diego, California, United States, 92101

Contacts

Danica Griffin

danica.griffin@sharp.com

Principal Investigator:

Kenneth Johnson

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

Christine Leonard

561-263-5768 christine.leonard@jupitermed.com

Principal Investigator:

Danielle Krol

Hope And Healing Care

Recruiting

Hinsdale, Illinois, United States, 60521

Contacts

Keerthana Kolluri

kkolluri@hopenheal.care

Principal Investigator:

Srilata Gundala

Investigative Clinical R of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Zara Edgell

zedgell@investigativeicr.com

Principal Investigator:

Ruemu Birhiray

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Alexandra Cline

+1 410 332 1200 acline@mdmercy.com

Principal Investigator:

David Andrew Riseberg

Maryland Oncology Hematology P A

Recruiting

Silver Spring, Maryland, United States, 20904

Contacts

Teresa Saavedra

teresa.saavedra@usoncology.com

Principal Investigator:

Carol Tweed

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Lauryn Vassel

617-632-5607 lauryn_vassel@dfci.harvard.edu

Principal Investigator:

Erica Mayer

Allina Hlth Cancer Inst Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jonathan Alexander

612-863-9466 jonathan.alexander@allina.com

Principal Investigator:

Daniel Carlson

Jackson Oncology Associates

Recruiting

Jackson, Mississippi, United States, 39202

Contacts

Teresa Davis

601-974-5547 tdavis@jacksononcology.com

Principal Investigator:

Justin T Baker

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68154

Contacts

Heather Cordes

+1 402 334 4773 hcordes@nebraskacancer.com

Principal Investigator:

Margaret Barbara Block

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

Catrin Davies

catrin.davies@duke.edu

Principal Investigator:

Madhu Chaudhry

Cone Health Cancer Center

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Nikki Eldreth

336-832-1100 Nikki.Eldreth@conehealth.com

Principal Investigator:

Vinay Gudena

Oncology Associates of Oregon PC

Recruiting

Eugene, Oregon, United States, 97401-8122

Contacts

Spencer Dandy

Spencer.dandy@usoncology.com

Principal Investigator:

Miho Dougherty

Northwest Cancer Specialists

Recruiting

Portland, Oregon, United States, 97210

Contacts

Heather Firneisz

971-708-7600 Heather.Firneisz@usoncology.com

Principal Investigator:

Jay Andersen

Oregon Oncology Specialists Salem

Recruiting

Salem, Oregon, United States, 97301

Contacts

Kyla Kinney

kkinney@orcancer.com

Principal Investigator:

Janelle Meyer

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Sarah Montini

sarah.montini@ahn.org

Principal Investigator:

Joseph Liput

Bon Secours St Francis Cancer Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Christine Sanchez

+1 864 603 6214 Christine_Sanchez@bshsi.org

Principal Investigator:

Stephen Howard Dyar

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Madeleine Enos

615-329-7270 madeleine.enos@scri.com

Principal Investigator:

Denise A Yardley

University of Texas

Recruiting

Houston, Texas, United States, 77030-4099

Contacts

Cynthia Tamez

713-794-5783 ctamez@mdanderson.org

Principal Investigator:

Jason Mouabbi

Bon Secours Virginia Health System

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Mary M Williams

804-894-8665 Mary_Williams7@bshsi.org

Principal Investigator:

William Irvin

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5T 3L9

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 19, 2026

Last verified

Oct, 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 2026-10-23. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.