USC Norris Launches Phase I Trial for Early Breast Cancer Blood Test
Researchers at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, have initiated a Phase I clinical trial to evaluate an investigational blood test designed to identify breast cancer earlier than conventional mammograms. The liquid biopsy functions as a complementary tool meant to be used alongside standard screening procedures to spot cellular and molecular indicators associated with early-stage disease.
Targeting Rare Cells and Extracellular Vesicles
Standard mammography remains the primary screening method for breast cancer, which is diagnosed in more than 300,000 women annually in the United States. However, abnormal mammogram results often necessitate supplementary imaging, tissue biopsies, or six-month follow-up examinations. These mandatory waiting periods can compound patient anxiety and potentially delay clinical intervention if a malignancy is present. While traditional liquid biopsies are typically deployed post-diagnosis to monitor therapeutic response or recurrence by analyzing fragmented tumour deoxyribonucleic acid, such genetic markers remain difficult to detect in small, early-stage tumours.
To overcome this limitation, the experimental assay isolates rare cancer-associated cells and tumour-associated large extracellular vesicles that enter the bloodstream during early disease development. By capturing these physical cellular components rather than relying solely on circulating DNA, the test aims to reflect early cellular activity more accurately.
Trial Design and Future Directions
The investigational diagnostic tool was developed at the USC Michelson Center Convergent Science Institute in Cancer by Peter Kuhn, a university professor and biological sciences dean at the USC Dornsife College of Letters, Arts and Sciences. As part of the ongoing Phase I study, participants will provide two blood samples across a 12-month interval. Researchers will then compare the results from the blood assay against standard diagnostic findings.
Trial principal investigator Anastasia Martynova, a breast cancer specialist, medical oncologist, and assistant professor of clinical medicine at Keck Medicine of USC, emphasized the goal of the study. Investigators hope to determine whether the assay can supply supplementary information during the critical early stages of the disease when treatment may be more manageable. At present, the technology remains strictly investigational and cannot replace mammography or tissue biopsies.
If the Phase I trial yields successful outcomes, investigators intend to advance the research into a larger Phase II trial. Furthermore, study authors note that the underlying technology could eventually be adapted to screen for other solid tumours, including colon and lung cancers, pending further clinical validation.
