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RECRUITING
NCT05770531
PHASE2

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

Sponsor: Vanderbilt-Ingram Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-08-04

Completion Date

2028-10-01

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection for banking

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biospecimen Collection

Undergo blood sample collection for ctDNA evaluation

BIOLOGICAL

Sacituzumab Govitecan

Given by IV

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States