This research study seeks to improve the treatment of early-stage breast cancer by examining circulating tumor DNA (ctDNA). CtDNA, a biomarker found in the blood, may indicate the presence of residual disease after initial treatment. The study aims to determine if ctDNA analysis can help doctors personalize adjuvant therapies, such as radiation and systemic therapy, leading to more effective treatment plans. A significant focus is placed on including African American/Black patients, a population often underrepresented in genomic research. By analyzing ctDNA in this group, researchers hope to gain valuable insights into the disease's characteristics and improve treatment outcomes, ultimately reducing disparities in breast cancer care. This is a hybrid decentralized study where some if not all assessments may be performed close to your home.
This study includes 100 patients with early breast cancer who've had surgery. You'll join either the non-Black or Black participant group. Researchers will use your stored tumor tissue from surgery to create a test that detects circulating tumor DNA (ctDNA) in your blood. CtDNA can show if cancer cells remain after treatment. You'll give blood samples (about 3 tablespoons) when you start and roughly every three months for a year. These samples will be tested for ctDNA using Haystack Oncology's new method, a less invasive way to monitor your condition. You might give an extra sample before adjuvant treatment. Your doctor will be informed about your ctDNA results and can share them with you if you want to know the results. You must request to be told your results. Your results will not be automatically sent to you. The test is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA). The study is testing if this method accurately tracks the disease. Your doctor will still monitor you with standard tests. You can have blood drawn at your local clinic. Researchers at UNC-CH will use your stored tumor tissue. You can also choose to donate leftover tissue to a biobank for future research. By participating, you allow researchers to use your stored tissue and blood to study how ctDNA can help monitor and treat breast cancer. Only extra tissue and blood not needed for your care will be used. If your doctor needs to collect samples for your.
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Yara Abdou
LCCC - Clinical Trials
Clinical or Medical
Observational
Cancer (Breast)
25-1235