Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT05827081
Trial Phases:	Phase III	Protocol IDs:	CLEE011O12001 (primary) NCI-2025-04264 2022-503001-38-00
Eligibility:	18 - 100 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT05827081

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).

Objectives

The study consists of Screening, Treatment, and Follow-up periods.

- Treatment Period: all participants who complete screening will receive ribociclib
400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with
daily ET for 36 months (approximately 39 cycles) from the date of first dose. The
Treatment Period starts when the patient receives their first dose of ribociclib and
ends at the time of the 30-day Safety Follow-up. All treated participants should
have a Safety Follow-up call conducted 30 days after the last dose of study
treatment.

- Follow-up period: participants will be followed from 30 days after study treatment
(i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until
death, withdrawal of consent, lost to follow-up, or until 48 months after the last
participant has received their first dose of study treatment (i.e. End of Study
[EOS]), whichever occurs first.

Treatment Sites in Georgia

University Cancer and Blood Center, LLC - Athens Medical Oncology
3320 Old Jefferson Road
Building 800
Athens, GA 30607
www.universitycancer.com

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