NIH Awards $6.4 Million Grant for Breast Cancer Biomarker Research

Advancing biomarker research may help determine which patients with non-invasive breast cancer will develop invasive disease.

Recently, the Albert Einstein College of Medicine and Hackensack University Medical Center announced they have received a $6.4 million grant from the National Institutes of Health (NIH) to research biomarkers that may help detect which patients with pre-cancerous tissue may develop breast cancer, according to a press release.

The researchers expect that advances in biomarker research may help personalize breast cancer treatment and improve survival.

Ductal carcinoma in-situ (DCIS) is a known precursor to invasive disease and has become a more common diagnosis due to an uptick in screening. Approximately 14% to 53% of patients with untreated DCIS develop invasive breast cancer (IBC) within 30 years of diagnosis, according to the release.

Currently, providers are unable to determine which patients will develop IBC. This can lead to over- or under-treatment for DCIS. Patients may receive unnecessary radiation and chemotherapy or they may not receive life-saving treatment.

“A diagnosis of DCIS presents patients with a difficult and stressful dilemma in terms of how to treat the condition,” said co-principal investigator Thomas Rohan, MBBS, PhD, DHSc. “A clinical test that could help accurately predict a patient’s prognosis would be enormously helpful and provide some much needed direction for settling on a plan of care.”

In the study, the researchers will assess an investigational assay that measures p16, COX-2, and Ki67 gene expression, which are all involved with cell proliferation, according to the release. The study will also explore the role microRNAs may play in the development of IBC.

The discovery of these biomarkers may lead to revolutionary treatments for patients at high risk of developing IBC, including drugs that target molecular changes known to lead to invasive disease, according to the release.

The studies will include clinical data and tissue samples from more than 7000 patients with DCIS who were followed to determine whether they developed IBC. The investigators plan to examine the samples to validate miRNA expression alterations linked to IBC; risk of IBC in relation to 2 previous biomarkers; and the link between clinical factors and risk of IBC, according to the release.

“We have concentrated our efforts on developing state-of-the-art molecular tools to better understand the natural history of DCIS lesions, with hope to complement current histological and immunohistochemical assays and improve personalized prognostic for women diagnosed with this disease” said co-principal investigator Olivier Loudig, PhD.