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Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

NCT05827081 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DRUG

Ribociclib

Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest

DRUG

Letrozole

Letrozole 2.5 mg orally once daily continuously

DRUG

Ansastrozole

Anastrozole 1 mg orally once daily continuously.

DRUG

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

DRUG

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

DRUG

Exemestane

Exemestane 25 mg once daily continuously

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-28
Primary Completion
2029-09-07
Completion
2030-09-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • China
  • Germany
  • Hong Kong
  • India
  • Israel
  • Mexico
  • Portugal
  • Puerto Rico
  • South Korea
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827081 on ClinicalTrials.gov