Clinical trialNCT05827081RecruitingPhase 3Interventional

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

SponsorNovartis PharmaceuticalsEnrollment1,400Early Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

228 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina

Novartis Investigative Site
Caba, Buenos Aires, Argentina
Recruiting
Novartis Investigative Site
La Plata, Buenos Aires, Argentina
Recruiting
Novartis Investigative Site
Córdoba, Argentina
Recruiting

Australia

Novartis Investigative Site
Gateshead, New South Wales, Australia
Active, not recruiting
Novartis Investigative Site
Tiwi, Northern Territory, Australia
Active, not recruiting
Novartis Investigative Site
Clayton, Victoria, Australia
Active, not recruiting
Novartis Investigative Site
East Melbourne, Victoria, Australia
Active, not recruiting

Brazil

Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Recruiting
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Recruiting
Novartis Investigative Site
Rio de Janeiro, Brazil
Recruiting
Novartis Investigative Site
Rio de Janeiro, Brazil
Recruiting
Novartis Investigative Site
São Paulo, Brazil
Recruiting

Canada

Novartis Investigative Site
Victoria, British Columbia, Canada
Active, not recruiting
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Recruiting
Novartis Investigative Site
Oakville, Ontario, Canada
Active, not recruiting
Novartis Investigative Site
Ottawa, Ontario, Canada
Active, not recruiting
Novartis Investigative Site
Toronto, Ontario, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Montreal, Quebec, Canada
Recruiting
Novartis Investigative Site
Québec, Quebec, Canada
Recruiting
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada
Recruiting

China

Novartis Investigative Site
Beijing, Beijing Municipality, China
Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, China
Active, not recruiting
Novartis Investigative Site
Harbin, Heilongjiang, China
Active, not recruiting
Novartis Investigative Site
Zhengzhou, Henan, China
Active, not recruiting
Novartis Investigative Site
Zhengzhou, Henan, China
Active, not recruiting
Novartis Investigative Site
Nanjing, Jiangsu, China
Recruiting
Novartis Investigative Site
Nanchang, Jiangxi, China
Active, not recruiting
Novartis Investigative Site
Changchun, Jilin, China
Active, not recruiting
Novartis Investigative Site
Jinan, Shandong, China
Active, not recruiting
Novartis Investigative Site
Jinan, Shandong, China
Active, not recruiting
Novartis Investigative Site
Jining, Shandong, China
Active, not recruiting
Novartis Investigative Site
Chengdu, Sichuan, China
Active, not recruiting
Novartis Investigative Site
Chengdu, Sichuan, China
Active, not recruiting

188 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AnsastrozoleExemestane →Goserelin →Letrozole →Leuprolide →Ribociclib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 28 Feb 2024
Primary completion: 7 Sept 2029
Completion: 20 Sept 2030
Last update posted: 21 Aug 2026
Registered enrollment: 1,400
Registry id: NCT05827081

Cross-registrations

EU-CTR / CTIS (EudraCT)2022-503001-38-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.