RecruitingPhase IIEN original

Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Rak piersi, który dał przerzuty do innych części ciała (stadium IV).
  • Rak, który nie reaguje na hormony (ER, PR ujemny) ani HER2 (HER2 ujemny).
  • Rak, który nie jest wrażliwy na leczenie wspomagające odporność (PD-L1 ujemny).
  • Choroba, którą można zmierzyć za pomocą badań obrazowych (np. tomografii).
  • Pacjent ma 18 lat lub więcej.
  • Ogólny stan zdrowia pozwala na umiarkowaną aktywność (grupa ECOG 0-2).
  • Pacjent rozumie i zgadza się wziąć udział w badaniu.
  • Pacjent nie był wcześniej leczony chemioterapią z powodu choroby, która dała przerzuty.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 24, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, United States

Trial contact

Vanderbilt-Ingram Services for Timely Access

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.