NEW YORK – Reveal Genomics and the Istituto Europeo di Oncologia (IEO) in Italy on Tuesday announced the launch of a study to evaluate the ability of Reveal's HER2DX test to guide treatment decisions for patients with early-stage HER2-positive breast cancer.
In the prospective observational study, researchers will collect data from oncologists, who will complete surveys about their patients' neoadjuvant treatment plans before requesting HER2DX and after receiving the results. Researchers from IEO will also measure patients' clinical and pathological variables, as well as response to neoadjuvant treatment.
The study will provide data on how useful the HER2DX test is to oncologists, how they use it to recommend treatments, and how it benefits patients. Researchers will also assess how HER2DX can be incorporated into routine clinical practice.
The study is being led by Carmen Criscitiello, a medical oncologist at IEO, and funded by Umberto Veronesi Foundation.
The 27-gene expression HER2DX test was introduced in Europe in 2022, as a way to determine the likelihood of breast cancer recurrence and predict whether patients will respond to different anti-HER2 drugs. The predictive and prognostic test integrates information on breast cancer patients' tumor size and nodal status with information about immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.
Earlier this year, Reveal began a clinical validation study of HER2DX in early-stage breast cancer in collaboration with Hospital Clinic Foundation for Biomedical Research and the consortium August Pi i Sunyer Biomedical Research Institute. The test is also included in the ongoing CompassHER2 pCR trial led by the ECOG-ACRIN Cancer Research Group, in which researchers are predicting breast cancer patients' outcomes on neoadjuvant treatment with paclitaxel and Genentech's HER2-targeted drugs Herceptin (trastuzumab) and Perjeta (pertuzumab).