NCT05770531

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: \- To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone. PRIMARY OBJECTIVE: I. To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved progression-free survival (PFS) compared to control patients assessed conventionally with imaging alone. SECONDARY OBJECTIVES: * To evaluate the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone. * To determine whether patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics demonstrate improved PFS2 compared to control patients assessed with conventional imaging alone. * To evaluate overall survival (OS) in patients with metastatic TNBC who undergo treatment changes guided by ctDNA dynamics compared to control patients assessed by conventional imaging alone. EXPLORATORY OBJECTIVES: * To evaluate for unique predictive values of ctDNA-defined clones identified through the blood-based analysis. * To correlate ctDNA changes with standard imaging. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for banking on study. ARM B: Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for ctDNA evaluation on study. Patients may receive sacituzumab govitecan intravenously (IV) based on ctDNA results on study. Patients in both arms A and B undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study. After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months and then every 6 months for 3 years.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-04
• Primary completion: 2028-08-01
• Completion: 2028-10-01
• First posted: 2023-03-15
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study