RecruitingNCT06230185

CtDNA Based MRD Testing for NAC Monitoring in TNBC

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)

Sponsor

Personalis Inc.

Enrollment

422 participants

Start Date

Nov 9, 2023

Study Type

OBSERVATIONAL

Conditions

TNBC - Triple-Negative Breast Cancer Minimal Residual Disease

Summary

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood test that detects tiny fragments of cancer DNA (called ctDNA or liquid biopsy) to monitor how well chemotherapy given before surgery is working in patients with triple-negative breast cancer (TNBC). **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer (hormone receptor-negative and HER2-negative) - Your cancer is early-stage (stage I-III) and you are scheduled to receive chemotherapy before surgery - You are willing to provide blood samples at multiple time points during treatment - Biopsy tissue is available **You may NOT be eligible if...** - You are receiving treatment for another active cancer at the same time - You are not scheduled to receive neoadjuvant (pre-surgery) chemotherapy - You are unwilling or unable to provide blood samples 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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Locations(14)

Arizona Oncology

Tucson, Arizona, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

George Washington University

Washington D.C., District of Columbia, United States

Mount Sinai Medical Center of Florida

Miami Beach, Florida, United States

Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC

St. Petersburg, Florida, United States

Illinois Cancer Care

Peoria, Illinois, United States

Louisiana State University

New Orleans, Louisiana, United States

Trinity Health-Michigan

Ypsilanti, Michigan, United States

Nebraska Methodist

Omaha, Nebraska, United States

Stony Brook University Cancer Center

Stony Brook, New York, United States

Oregon Oncology Specialists

Salem, Oregon, United States

Cancer Care Associates of York

York, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cancer Care Northwest

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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

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NCT06230185

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