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NIH Grants $6.4 Million to Better Identify Breast Cancer Biomarkers


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Researchers at Albert Einstein College of Medicine, part of Montefiore, and Hackensack Meridian Health John Theurer Cancer Center at Hackensack University Medical Center have secured a 5-year, $6.4 million grant from the National Institutes of Health (NIH) to identify biomarkers that may predict which women with precancerous tissue in their breast will develop invasive breast cancer. This research could help personalize treatment and improve outcomes for tens of thousands of women each year. The grant, which is titled “Molecular Markers of Risk of Subsequent Invasive Breast Cancer in Women With Ductal Carcinoma in Situ,” was awarded by the National Cancer Institute.

Ductal carcinoma in situ—increasingly detected thanks to the widespread use of mammography—is a precursor of invasive breast cancer. Approximately 50,000 women are diagnosed with the disease each year. When ductal carcinoma in situ goes untreated, between 14% and 53% of patients develop invasive breast cancer in the 3 decades following diagnosis. Unfortunately, it’s not possible to tell which patients with ductal carcinoma in situ will go on to develop invasive breast cancer. As a result, individual women are often overtreated or undertreated—either suffering debilitating radiation or chemotherapy treatments they do not need or skipping potentially life-saving therapies.

Experimental Assay

As part of their effort to develop a prognostic test for invasive breast cancer risk, Einstein and Hackensack University Medical Center researchers will evaluate a promising experimental assay that measures the expression of three genes—p16, COX-2, and Ki67—implicated in cell proliferation. They will also instigate novel research into microRNAs, noncoding RNAs that regulate gene expression and are thought to contribute to the development of invasive cancer.

Such markers might also help improve treatment for women found to be at high risk for invasive breast cancer —by leading, for example, to novel agents that target molecular changes associated with invasive-disease development.

Researchers will use clinical data and archived tissue samples from a cohort of more than 7,000 patients diagnosed with ductal carcinoma in situ and who were followed to see if they later developed invasive breast cancer. They will evaluate the samples to identify and validate miRNA expression changes associated with risk for subsequent invasive breast cancer; evaluate risk of invasive breast cancer in association with two previously identified sets of markers, including Oncotype DX ductal carcinoma in situ score; and examine the association between clinical factors and risk for subsequent invasive breast cancer. ■


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