Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Clinical stage IV (metastatic) estrogen receptor (ER), PR, HER2 negative invasive mammary carcinoma, previously documented by histological analysis and that meets the following criteria: * 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 * Immunohistochemistry (IHC) 0 or IHC 1+ (if more than one test result is available and not all results meet the inclusion criterion definition, all results should be discussed with the sponsor-investigator to establish eligibility of the patient) * ER and PR negativity are defined as =\< 10% of cells expressing hormonal receptors via IHC analysis * PD-L1 negative (combined positive score \[CPS\] \< 10) or otherwise not appropriate for checkpoint inhibitors * Patients must have measurable disease according to the standard RECIST version 1.1 \* NOTE: CT s