A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic Triple Negative Breast Cancer
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.
• 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 scans or MRIs used to assess the measurable disease must have been completed with 28 days prior to the study drug initiation
• Patients must be age \>= 18 years; both male and female are eligible
• Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
• No prior chemotherapy regimens for metastatic disease
• Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained less than 28 days from initiation of study drug)
• Platelet count \>= 100,000/mm\^3 (obtained less than 28 days from initiation of study drug)
• Bilirubin, serum glutamic oxaloacetic transaminase (SGOT), serum glutatmic pyruvic transaminase (SGPT), alkaline phosphatase =\< 4x upper limits of normal if no liver metastases present
• Serum total bilirubin must be \< 3x upper limits of normal for patients with Gilbert disease
• Total bilirubin, SGOT, SGPT =\< 6x upper limits of normal if liver metastases present (obtained less than 28 days from initiation of study drug)
• For patients who are not postmenopausal (women) or surgically sterile (absence of ovaries and/or uterus or vasectomy), agreement to remain abstinent or to use two adequate methods of contraception (e.g., condoms, diaphragm, vasectomy/vasectomized partner, tubal ligation), during the treatment period and for at least 30 days after the last dose of study treatment. Hormone based oral contraceptives are not allowed on study. Postmenopausal is defined as:
‣ Age \>= 55 years
⁃ Age =\< 55 years and amenorrheic for 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; or follicle stimulating hormone and estradiol in the postmenopausal range