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Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

NCT05467891 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-08

No results posted yet for this study

Summary

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Conditions

Interventions

DRUG

Ribociclib

400 mg orally once daily Days 1-21 (28 day Cycle)

DRUG

Fulvestrant

500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+

DRUG

Anastrozole

1 mg orally once daily

DRUG

Letrozole

2.5 mg orally once daily

DRUG

Exemestane

25 mg orally once daily

Sponsors & Collaborators

Principal Investigators

  • Oana Danciu, MD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2028-08-15
Completion
2029-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT05467891 on ClinicalTrials.gov