This Small Bbusiness Innovation Research (SBIR) Phase II project aims to continue the validation of a set of markers for predicting recurrence and guiding the selection of treatment in stage I-III breast cancer patients. Upon removal of their primary stage I-III operable tumors, breast cancer patients must decide whether or not to receive adjuvant therapy such as chemotherapy, or hormone therapy. Currently, the physician and patient can arrive at the decision by relying on several published guidelines whose accuracy is limited by the fact that they are based on general clinicopathologic data such as tumor size and grade. Thus the majority of patients are recommended to receive adjuvant therapy, although only a small fraction of them benefit from it.
Availability of a set of reliable markers that can predict recurrence of tumors would allow tailoring of adjuvant therapy for each patient and is thus likely to reduce the chances of under-treatment and over-treatment. As such, it would be of great benefit to cancer patients, as well as to oncologists.
One of the most critical decisions for a breast cancer patient and her oncologist is to decide on the need for adjuvant chemotherapy in patients with invasive breast carcinoma. While the need for adjuvant hormone therapy is mainly determined by hormone receptor positivity, there is a great need for medical tools to accurately indicate whether or not adjuvant chemotherapy is needed. Currently chemotherapy is over prescribed, has severe short and long term side effects, and only benefits a small percentage of patients. Prediction Sciences developed the InsightDX Breast Cancer Profile as a result of our Phase I, Phase II, and Phase IIB NSF SBIR grant. InsightDX Breast Cancer Profile is a multiple marker breast cancer prognostic test, based on 7 molecular markers and 3 clinical-pathologic variables. Combined, these give a result called the InsightDx Breast Cancer Score (IDX). This IDX score classifies patients as low or high risk of recurrence if only given hormone therapy. Based on this classification, patients and oncologist may make an informed decision on whether to prescribe adjuvant chemotherapy. In addition to the full validation of our current test, our study also investigated 5 additional markers to see if they add any predictive value. A single marker, Cav1, was identified that was shown to enhance the predictive ability of InsightDx Breast Cancer for the specific purpose of showing chemotherapy benefit to a high risk of recurrance patient. The result of this grant is that the InsightDx Breast Cancer Profile was shown to be highly predictive of risk of recurrence in a blinded multi-site clinical trial patient validation, the fifth independent dataset on which it has been validated. The InsightDx Breast Cancer Profile is commercially ready to benefit breast cancer patients at a lower cost than current premium priced tests on the market.
