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Novel Genomic Test Under Study in Early-Stage Triple-Negative Breast Cancer

By: Chris Schimpf, MSW
Posted: Wednesday, October 16, 2024

A team of researchers has developed a genomic test that may prove useful in identifying biomarkers to tailor treatment strategies in early-stage triple-negative breast cancer (TNBC). Miguel Martín Jiménez, MD, PhD, of Hospital General Universitario Gregorio Marañón, Madrid, and colleagues found that their TNBC-DX genomic test predicted response to neoadjuvant taxane/carboplatin chemotherapy in early-stage TNBC, and it helped forecast patients’ long-term survival in the absence of neoadjuvant anthracycline, cyclophosphamide, and immunotherapy. The team presented their findings at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 237MO).

To develop the test, the investigators used as their starting point the HER2DX assay developed for HER2-positive breast cancer and evaluated its potential for improvement using data from three separate trials (n = 1,120). They then defined the pathologic complete response and risk scores of the TNBC-DX genomic test, both as a continuous score and group categories using a predefined cutoff. Finally, they validated the model in 418 patients with stage I to III early-stage TNBC undergoing neoadjuvant taxane-based chemotherapy without anthracycline/cyclophosphamide and pembrolizumab from two external cohorts.

The investigators reported that the TNBC-DX pathologic complete response score as a continuous score was significantly associated with pathologic complete response rates in both cohorts individually (P < .01). Furthermore, the combined rates for the pathologic complete response–high, –medium, and –low categories were 57.2%, 43.9%, and 16.7%, respectively (odds ratio for pathologic complete response–high vs pathologic complete response–low = 6.69; P < .001). Additionally, the TNBC-DX risk score was found to be significantly associated with distant disease–free survival (hazard ratio [HR] for high-risk vs low-risk = 3.06; P < .001) and overall survival (HR = 3.11; P < .001). This association remained statistically significant after the investigators accounted for pathologic complete response status.

Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.


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