Researchers at the Indiana University School of Medicine are embarking on a phase two clinical trial, called PERSEVERE, with the hope of developing personalized therapies for triple-negative breast cancer patients. Led by IU’s Dr. Bryan Schneider, this nationwide study will help researchers better understand how to treat patients with triple-negative breast cancer, based on their own genetic data. Schneider says there is a tremendous need for successful triple-negative breast cancer treatments because recurrence and death rates are still too high. The PERSEVERE study builds on a previous discovery by Schneider and colleagues that enabled better prediction of disease recurrence or disease-free survival. While approximately one-third of patients with triple-negative breast cancer will achieve remission after surgery and chemotherapy, two-thirds will still have some cancerous tissue in their body. The PERSEVERE study will enroll 200 participants and test whether there is circulating tumor DNA, or ctDNA, in their blood. Research has shown that patients who test positive for ctDNA after surgery are at higher risk of their cancer returning. If a patient does test positive for ctDNA, the researchers will look at the DNA of their blood and tumor to see if there are any genetic differences that can be treated with a genomically-targeted therapy or a standard treatment. If they test positive but researchers determine they do not have a specific genomic target in their blood or cancer tissue, the patient will receive standard treatment recommended by their doctor. Patients who test negative for ctDNA may receive standard treatment, but they can also decline additional treatment and choose observation. Schneider says because circulating tumor DNA is a powerful tool for identifying risk, the researchers will capitalize on that ability to better focus their attention on patients who are extraordinarily high risk or have ctDNA positivity. However, Schneider says, the researchers also will focus on those who do not test positive for ctDNA, a group that may be expected to do quite well in terms of de-escalating therapy and improving quality of life.
In other news, IU researchers Brea Perry and Anne Krendl, who are part of IU’s Responding to the Addictions Crisis Grand Challenge, helped develop the newly launched Shatterproof Addiction Stigma Index, a first-of-its-kind research tool designed to establish a baseline measure of public attitudes and beliefs about substance use disorders and to monitor stigma related to them over time. Perry and Krendl say the index, co-developed by Shatterproof and the Hartford, will also measure the perceptions of people with substance use disorders, including experiences of social exclusion and internalized stigma. The new addiction stigma index measures public stigma, structural stigma, and self-stigma, which helps provide a more comprehensive understanding of stigma. By repeating the index biannually, it will be possible to regularly measure changes in these distinct but interrelated components of stigma. Results from the survey provide critically important information, the researchers say. Quantifying the extent and nature of negative perceptions of individuals with substance use disorders is the first step toward changing them. With a comprehensive set of more than 50 measures of stigma completed by a representative sample of nearly 8,000 United States residents, Perry and Krendl say this is the largest and most expansive survey of addiction stigma ever fielded. By establishing a benchmark for future measurement, the index will provide a robust tool to gauge progress. The researchers say the country has an opportunity and obligation to chart a new path informed by rigorous research and data to dismantle the discrimination and misinformation that threatens recovery.