This two-gene assay identifies breast cancer patients who are likely to achieve long-term survival with tamoxifen treatment alone. This risk stratification tool accurately guides therapeutic decisions, sparing patients from other toxic adjuvant chemotherapies that provide little or no additional benefit.
Patients with estrogen receptor positive (ER+) breast cancer can be treated with tamoxifen, which improves survival in those patients. However, it has been historically difficult to define which patients with ER+ breast cancer might benefit from additional treatment using chemotherapies. Because there is not a clear methodology for separating the patients who need chemotherapy from those who only need a tamoxifen treatment, there is a population of ER+ cancer patients receiving chemotherapy—and the toxic effects of this kind of treatment—unnecessarily.
Researchers at Wake Forest Baptist Medical Center have developed an assay based on two genes (ferroportin and hepcidin) that can accurately stratify ER+ breast cancer patients, identifying individuals who have a high likelihood of long-term survival with tamoxifen treatment alone.
Ferroportin and hepcidin are good predictors of response to chemotherapy thereby providing useful guidance to the clinician. Because iron facilitates cell proliferation and growth, it can contribute to tumor initiation and tumor growth. Both ferroportin and hepcidin play an important role in iron homeostasis in cells.
- A study in over 800 patients demonstrated that the assay can predict metastasis-free survival—based on decreased ferroportin gene expression—even in lymph node-positive patients, unlike Mammaprint and Oncotype Dx
- Assay is independent of other outcome predictors—including tumor size, grade and age—making it a strong indicator of patient survival that can guide physicians and patients in treatment decisions
- Survival rate predicted by only two genes is comparable to that of other more expensive assays requiring assessment of 21 genes (Oncotype Dx) or even 70 genes (Mammaprint)
Widespread commercial application as a prognostic indicator and predictor for the treatment of breast cancer, can be applied to other cancers including prostate cancer
Stage of Development
Assay is available for development as an in vitro diagnostic or CLIA-approved laboratory test for clinical testing.
- Lance Miller, PhD, Department of Cancer Biology
- Suzy Torti, MD, Department of Molecular Biology and Biophysics, University of Connecticut Health Center
- Frank Torti, MD, Department of Medicine, University of Connecticut Health Center
Breast cancer assay, cancer, chemotherapy, adjuvant therapy
US Application 14/250,303
EPO Application 10822794.3
Pinnix, Z. et al. (2010). Ferroportin and Iron Regulation in Breast Cancer Progression and Prognosis. Sci Transl Med, 2(43), 43.
Miller, L. et al. (2011). An Iron Regulatory Gene Signature Predicts Outcome in Breast Cancer. Cancer Research, 71(21), 6728-37.
Tesfay, L. et al. (2015). Hepcidin Regulation in Prostate and Its Disruption in Prostate Cancer. Cancer Research, 75(11), 2254-63.
Peter Golikov, MS, MBA, CLP
Center for Technology Innovation & Commercialization
Reference #: WFU 10-15