Researchers at Keck Medicine of USC launched a phase 1 clinical trial evaluating an experimental blood-based liquid biopsy designed to detect early-stage breast cancer alongside standard mammograms. The study is funded by the National Cancer Institute and the Breast Cancer Research Foundation.
Evaluating Phase 1 Trial Design and Accuracy
The study investigates whether a simple blood draw can catch molecular signs of malignancy as early as stage I. Principal investigator Anastasia Martynova, MD, a breast cancer specialist and medical oncologist at the USC Norris Comprehensive Cancer Center, hopes the test will provide critical detection clues during the most treatable phases of the disease. Participants in the trial provide two blood samples spaced one year apart. Investigators then compare these assay results against each patient’s actual clinical diagnosis to measure diagnostic accuracy.
Unlike standard liquid biopsies that primarily track disease progression or recurrence after a formal diagnosis, this platform targets rare cancer-associated cells. The technology also screens for tumor-associated large extracellular vesicles, or L-EVs. These microscopic particles shed by cancer cells reach the bloodstream during initial stages of growth and reveal dynamic cellular communications between the tumor and its surrounding microenvironment.
Expanding screening access for remote patients
Beyond supplementing routine radiological exams, investigators are exploring whether the blood test can expand access to care. Co-investigator Amanda M. Woodworth, MD—who serves as director of breast health at Keck Medicine and Henry Mayo Newhall Hospital in Santa Clarita—remarked that this assay could serve as a substitute screening method for people hindered by geographical obstacles to mammography, including those residing in isolated regions lacking robust healthcare systems. Woodworth also noted potential utility for patients who have undergone a mastectomy, for whom traditional mammograms are no longer viable.
Peter Kuhn, PhD—a University Professor and Dean’s Professor of Biological Sciences at the USC Dornsife College of Letters, Arts and Sciences—developed the foundational rare-cell and extracellular-vesicle detection technology at the University of Southern California. Researchers believe the same platform could eventually be adapted to screen for other solid tumors, including lung and colon cancers.
Adhering to standard screening guidelines during trials
The test remains strictly investigational and does not replace standard mammograms or tissue biopsies. No trial results are available yet. If the phase 1 trial yields positive findings, the research team plans to advance to a larger phase 2 study involving more patients. In the interim, health guidelines advise average-risk women to follow standard screening protocols—such as mammograms every two years starting at age 40—and promptly report new lumps, skin dimpling, persistent pain, or nipple discharge to a clinician.
Frequently Asked Questions
Does the new blood test replace mammograms?
No. Researchers emphasize that the liquid biopsy is still in a phase 1 clinical trial and does not replace standard mammograms or tissue biopsies.
Who is funding and leading the clinical trial?
The trial is funded by the National Cancer Institute and the Breast Cancer Research Foundation, with Anastasia Martynova, MD, serving as the principal investigator at the USC Norris Comprehensive Cancer Center.
How do participants contribute to the study?
Participants provide two blood samples spaced one year apart, which researchers then compare against the patients’ clinical diagnoses to evaluate test accuracy.
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