Breast Cancer Diagnostics

Breast cancer is the most commonly diagnosed cancer in females in the United States. In 2018, approximately 266,120 new cases of breast cancer have been diagnosed and 40,920 deaths have been documented. Detection of breast cancer at earlier stages is associated with increased survival rates. Therefore, improved detection methods will reduce the morbidity and mortality rates associated with breast cancer. The Walt lab is currently developing a novel blood test for breast cancer detection using Single Molecule Arrays. A blood test for breast cancer will improve early detection, reduce the need for unnecessary biopsies, and reduce the mortality rate associated with breast cancer. Additionally, a blood test could provide molecular information enabling early and accurate detection, subtyping, and guiding treatment.

Breast Cancer Screening:

The term “breast cancer” refers to a group of diseases with heterogeneous biologies that lead to varied clinical phenotypes. Over the past several decades, the mortality rate associated with breast cancer has decreased in part due to mammographic screening. However, mammographic screening for breast cancer has major limitations including a high false-positive rate, resulting in unnecessary biopsies, and a high false-negative rate, resulting in undiagnosed cancers that potentially require treatment. Based on statistics from the National Cancer Institute, approximately 50% of women screened annually for 10 years in the U.S. will experience a false-positive mammogram, and of these women, up to 17% will have unnecessary biopsies. Additionally, mammograms have a high false-negative rate and can miss up to 20% of clinically relevant breast cancers. Therefore, improved detection methods will reduce the false-positive and false-negative rates. Another major limitation with current detection modalities is overdiagnosis of breast cancer. Overdiagnosis of breast cancer means that a patient is diagnosed with cancer, however, the cancer does not require treatment since the disease will never cause symptoms or death during the patient’s lifetime. Traditionally, diagnosed breast cancers are treated with standard clinical care, including surgery, chemotherapy, and radiation. This results in overtreatment of patients who do not need treatment, leading to high morbidity. An accurate blood test for breast cancer will result in early detection of breast cancers that require treatment.

Monitoring Response to Therapy and Recurrence:

Methods to monitor response to treatment are limited. At least 15% of patients with breast cancer experience either local recurrence or metastasis. This number is even higher for patients with triple negative and HER2 positive disease. We are interested in determining how quickly and completely a patient returns to a healthy profile using a simple blood test. Detecting a return to more normal levels of biomarkers during treatment will indicate that the tumor burden has been reduced. Some patients may initially respond but may never normalize, indicating presence of residual disease. In addition, for some treatment modalities, a complete lack of response will be observed, which could help guide clinicians to alter the treatment regimen. Our goal is to monitor patients during the course of treatment and post-treatment to monitor a return to a healthy profile.