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Personalis to Test MRD Assay in Triple-Negative Breast Cancer Trial With ABRCC, Criterium

NEW YORK – Personalis said Tuesday that it has partnered with the Academic Breast Cancer Consortium (ABRCC) and Criterium to carry out a prospective clinical trial evaluating the clinical performance of its NeXT Personal test in patients with early-stage triple-negative breast cancer (TNBC).

The firm's assay, a tumor-informed blood test, is intended to detect minimal residual disease (MRD) in patients undergoing surgery or other treatment for their cancer, as well as to monitor patients after treatment for early signs of recurrence.

According to Personalis, TNBC tends to shed less circulating tumor DNA into the blood than other types of cancer, which makes it challenging to detect it with other MRD technologies. The firm aims to show that its approach, which uses whole-genome sequencing to develop personalized blood tests, can overcome this barrier.

In the trial, B-STRONGER-1 (Breast Cancer-Minimal Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I), Personalis will test samples from approximately 900 patients. Investigators plan to compare the MRD test results to clinical assessments of patients' pathological complete response (pCR) to neoadjuvant treatment. Researchers will then follow the cohort for five years to assess the predictive power of the company's test.

"While a valuable tool in estimating the risk of recurrence, pCR doesn’t help us to monitor for recurrence and response to treatment. More importantly, a large proportion of patients who do not have a pCR status have cancer recurrence," Pavani Chalasani, the study's principal investigator and director of the hematology/oncology division at George Washington Cancer Center, said in a statement.

"MRD testing has shown significant promise in recent years as a viable alternative, and it could become the new standard for assessing not only a patient's response to treatment, predicting their risk of recurrence, but also to detect early recurrence of disease," he added.