Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy

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

Trial Details

NCT ID
NCT05770531
Phase
PHASE2
Sponsor
Vanderbilt-Ingram Cancer Center
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Sacituzumab Govitecan
Locations (sample)
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis…
  • HER2 negativity is defined as any of the following by local laboratory assessment:
  • In-situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \< 2.0 or
  • Single probe average HER2 gene copy number \< 4 signals/cell), or

For full eligibility, visit ClinicalTrials.gov.

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