Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT05770531
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection for banking
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection for ctDNA evaluation
  • Sacituzumab Govitecan — BIOLOGICAL
    Given by IV

Study Details

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.

Key Dates

Start date
Aug 4, 2023
Status verified
Apr 2025
Primary completion
Aug 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (biospecimen banking)
    Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for banking on study. Patients undergo CT or MRI during screening and on study.
  • Experimental: Arm B (biospecimen evaluation, possible treatment change)
    Patients receive providers choice of standard of care chemotherapy and undergo blood sample collection for ctDNA evaluation on study. Patients may receive sacituzumab govitecan IV based on ctDNA results on study. Patients undergo CT or MRI during screening and on study.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Vandana Abramson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

Related Studies