RecruitingPhase 2NCT05770531

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

160 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether monitoring circulating tumor DNA (ctDNA) — fragments of cancer DNA shed into the bloodstream — can guide changes to chemotherapy in patients with metastatic triple-negative breast cancer (cancer that is estrogen receptor, progesterone receptor, and HER2 negative), allowing doctors to switch treatments earlier when the current therapy isn't working. **You may be eligible if...** - You have been diagnosed with stage IV (metastatic) triple-negative breast cancer (ER, PR, and HER2 negative), confirmed by biopsy - You have not yet received chemotherapy for your metastatic cancer - You have at least one measurable tumor on scans **You may NOT be eligible if...** - Your cancer is not triple-negative (has ER, PR, or HER2 expression) - You have already received chemotherapy for metastatic disease - You have poor organ function or health status that prevents chemotherapy 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

PROCEDUREBiospecimen Collection

Undergo blood sample collection for banking

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREBiospecimen Collection

Undergo blood sample collection for ctDNA evaluation

BIOLOGICALSacituzumab Govitecan

Given by IV


Locations(1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

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NCT05770531


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