Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

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.

Conditions

• Metastatic HER2-Negative Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Vandana Abramson, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-04

Primary Completion

2028-08-01

Completion

2028-10-01

FDA Drug

Yes

Countries

• United States

Study Locations