RecruitingPhase 2NCT04567420

DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

A Randomized, Phase II Trial of Circulating Tumor DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)

Sponsor

Criterium, Inc.

Enrollment

70 participants

Start Date

Feb 9, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tracks circulating tumor DNA — tiny cancer fragments found in the blood — in women with hormone receptor-positive, HER2-negative breast cancer who are at high risk of recurrence, to detect early signs of cancer coming back and potentially guide additional treatment decisions. **You may be eligible if...** - You have hormone receptor-positive (ER+), HER2-negative breast cancer at high risk of recurrence - You are currently taking or have recently completed adjuvant hormone therapy (such as an aromatase inhibitor or tamoxifen) for at least 6 months and no more than 7 years - You are at high risk, meaning you have 4 or more positive lymph nodes, or certain other high-risk features - Prior CDK4/6 inhibitor therapy (completed 12+ months ago) is allowed **You may NOT be eligible if...** - Your tumor is ER-negative (even if PR-positive) - Your cancer has already spread to distant organs - You are pregnant or breastfeeding - You have another active cancer 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

DRUGPalbociclib

4 week cycles

DRUGFulvestrant

4 week cycles

DRUGAdjuvant Therapy

Standard of Care

Locations(19)

University of Arizona Cancer Center

Tucson, Arizona, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Intermountain

Golden, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Louisiana State University Health Sciences Center- New Orleans

New Orleans, Louisiana, United States

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

The Ohio State University Wexner Medical Center James Cancer Hospital

Columbus, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

PRiSMs Group

Laredo, Texas, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04567420

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