RecruitingPhase 2NCT05467891

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

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

Sponsor

Oana Danciu

Enrollment

200 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Locoregional Recurrence

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ribociclib (a targeted cancer drug) combined with hormone therapy in pre-menopausal women with hormone receptor-positive, HER2-negative breast cancer that has come back after initial treatment. **You may be eligible if...** - You are a pre-menopausal woman with hormone receptor-positive (HR+), HER2-negative breast cancer - Your cancer has returned or spread (recurred or metastasized) - You have not previously received a CDK4/6 inhibitor (a specific class of targeted therapy) **You may NOT be eligible if...** - You have already been treated with ribociclib, palbociclib, or a similar CDK4/6 inhibitor drug - You have certain serious heart conditions (such as a prolonged QT interval) - Your liver function tests are significantly abnormal - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib

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

DRUGFulvestrant

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

DRUGAnastrozole

1 mg orally once daily

DRUGLetrozole

2.5 mg orally once daily

DRUGExemestane

25 mg orally once daily

Locations(20)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arizona

Phoenix, Arizona, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University of Michigan Health-West

Wyoming, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

New York University Clinical Cancer Center

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Penn State Cancer Institute

Hershey, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05467891

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