Personalis, ABRCC and Criterium Announce Major Prospective Clinical Trial
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TNBC accounts for approximately 15%-20% of breast cancers diagnosed worldwide and is associated with worse outcomes compared to other breast cancer subtypes. Recurrence may be difficult to detect with other MRD assays, as TNBC in its earlier stages tends to ‘shed’ less circulating tumor DNA (ctDNA), a key marker for residual or recurrent cancer.
“The relatively high rate of recurrence in early stage TNBC patients makes detection of MRD after treatment important for assessing therapy response and providing opportunities for earlier intervention,” said
Currently, a patient’s likelihood of developing a recurrent tumor is largely determined through pathological assessment of tissue samples collected from both the site of the primary tumor and regional lymph nodes following treatment—a process broadly referred to as pathological complete response (pCR) testing.
“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. Currently we do not have good options in the clinic for detecting early recurrence. If we find it via imaging scans, it is too late, as this means the cancer has established a new ‘home’ already,” explained the study’s principal investigator,
NeXT Personal leverages next-generation sequencing technology to detect ctDNA in the bloodstream and may enable detection of micrometastases that currently evade pCR detection. The assay is designed to deliver industry-leading MRD sensitivity down to 1 part-per-million, an approximately 10- to 100-fold improvement over other available technologies. This may enable earlier detection across a broader variety of cancers and stages.
The B-STRONGER-1 study will enroll approximately 900 patients at up to 30 US sites and will be carried out in two stages. In the first stage, samples will be collected from each patient for both pCR and MRD analyses, to assess whether MRD using NeXT Personal correlates with standard of care pCR measurements. The second stage will involve a five-year follow-up to deepen the evidence on performance and establish clinical utility of NeXT Personal in early stage resectable TNBC.
About Triple Negative Breast Cancer
Triple negative breast cancer (TNBC) is aggressive and strongly correlated with hereditary BRCA1/2 mutations as well as a higher prevalence in young