NCT05827081From ClinicalTrials.govRecruiting

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

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)

Early Breast Cancer

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Novartis Pharmaceuticals
Enrolment target: 1,400
Started: 28 February 2024
Main results due: 7 September 2029
Study sites: 229
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 100 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(229)

Central Alabama Research
Birmingham, Alabama, United States
Recruiting
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Recruiting
Western Reg MC-COH Phoenix
Goodyear, Arizona, United States
Recruiting
CARTI Cancer Center
Little Rock, Arkansas, United States
Recruiting
Beverly Hills Cancer Center
Beverly Hills, California, United States
Active, not recruiting
Onco Inst of Hope and Innovation
Cerritos, California, United States
Recruiting
City of Hope National Medical
Duarte, California, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
Los Angeles Cancer Network Good Samaritan
Los Angeles, California, United States
Recruiting
El Camino Hospital
Mountain View, California, United States
Recruiting
Palo Alto Medical Foundation
Mountain View, California, United States
Recruiting
UC Irvine Medical Center
Orange, California, United States
Recruiting
Sutter Inst Medical Research
Sacramento, California, United States
Recruiting
School Of Medicine
Sacramento, California, United States
Recruiting
Sharp Rees Stealy Medical Group Inc
San Diego, California, United States
Recruiting
AdventHealth Medical Group Hematology and Oncology
Denver, Colorado, United States
Withdrawn
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Recruiting
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Active, not recruiting
AdventHealth Altamonte Springs
Altamonte Springs, Florida, United States
Active, not recruiting
Holy Cross Health
Fort Lauderdale, Florida, United States
Recruiting
Hialeah Hospital
Hialeah, Florida, United States
Active, not recruiting
Memorial Cancer Institute
Hollywood, Florida, United States
Recruiting
Jupiter Medical Center
Jupiter, Florida, United States
Recruiting
Ocala Research Institute, Inc
Ocala, Florida, United States
Active, not recruiting
University Cancer and Blood Center LLC
Athens, Georgia, United States
Withdrawn
Summit Cancer Care PC
Savannah, Georgia, United States
Active, not recruiting
Hawaii Cancer Care
Honolulu, Hawaii, United States
Withdrawn
Affiliated Oncologists IL
Chicago, Illinois, United States
Recruiting
Hope And Healing Care
Hinsdale, Illinois, United States
Recruiting
Midwestern Reg MC COH Chicago
Zion, Illinois, United States
Active, not recruiting
Investigative Clinical R of Indiana
Indianapolis, Indiana, United States
Recruiting
University of Iowa Health Care
Waukee, Iowa, United States
Active, not recruiting
University of Kansas Cancer Center
Westwood, Kansas, United States
Active, not recruiting
Cancer Center of Kansas
Wichita, Kansas, United States
Active, not recruiting
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States
Recruiting
Mercy Medical Center
Baltimore, Maryland, United States
Recruiting
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States
Recruiting
Boston Medical Center
Boston, Massachusetts, United States
Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Dana Farber Brigham Women Cancer
Milford, Massachusetts, United States
Withdrawn
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, United States
Recruiting
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota, United States
Recruiting
Jackson Oncology Associates
Jackson, Mississippi, United States
Recruiting
HCA Midwest Division
Kansas City, Missouri, United States
Recruiting
WA Uni School Of Med
St Louis, Missouri, United States
Active, not recruiting
Intermountain Healthcare
Billings, Montana, United States
Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Active, not recruiting
Cancer Care Specialists
Reno, Nevada, United States
Recruiting
MD Anderson Cancer Center At Cooper
Camden, New Jersey, United States
Recruiting
Summit Health
Florham Park, New Jersey, United States
Recruiting
The Valley Hospital
Ridgewood, New Jersey, United States
Recruiting
Presbyterian Medical Group
Albuquerque, New Mexico, United States
Recruiting
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Recruiting
Optum Health
Lake Success, New York, United States
Recruiting
Mount Sinai School of Medicine
New York, New York, United States
Recruiting
Duke Cancer Network
Durham, North Carolina, United States
Recruiting
Cone Health Cancer Center
Greensboro, North Carolina, United States
Recruiting
Sanford Research USD Fargo
Fargo, North Dakota, United States
Active, not recruiting

Showing 60 of 229 sites — filter to narrow it down. 101 of the 229 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05827081. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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