Clinical Trial Data Model: What Can It Offer Health-Care Professionals Who Treat Breast Cancer?
Posted: Thursday, November 18, 2021
According to research presented in JCO Clinical Cancer Informatics, analysis and visualization of aggregate data sets from cancer clinical trial landscapes may help inform treatment approaches and strategic planning for future trial structures. Trials focused on breast cancer, which is associated with the curation of protein and cytogenetic biomarkers, are a good candidate for such analysis through the My Cancer Genome clinical trial curation and data model, according to Mia Levy, PhD, of Rush University Medical Center in Chicago, and colleagues.
“Aggregate views of these data, particularly data associated with diseases, biomarkers, and drugs, can be helpful in understanding the trends in current research as well as existing gaps in cancer care,” the investigators noted.
Between June 2012 and December 2019, 1,128 clinical trials comprising 1,881 clinical trial arms were reviewed. Across all trials, biomarkers related to estrogen receptor and progesterone receptor protein expression and those associated with the amplification or protein expression of HER2 were the most common. A significant number of trials were associated with BRCA1, BRCA2, and PIK3CA mutations. Trials focused on metastatic settings were most common (n = 800), followed by neoadjuvant (n = 226) and adjuvant (n = 121) settings. The most widely used treatments were cytotoxic therapy (n = 1,023), tyrosine kinase inhibitors (n = 571), and hormonal therapy (n = 458). HER2-negative disease (n = 638) and triple-negative breast cancer (n = 553) were the focus of the largest quantities of trial arms.
A total of 479 treatments were evaluated across all trials; during the same time frame, 68 treatments were approved for use in breast cancer. A disproportionately high number of trials focused on triple-negative breast cancer, given its relative rarity of occurrence. Despite the high number of trials opened during this period, low enrollment was a persistent challenge, suggesting that multiple trials exploring similar treatments may benefit from being collapsed into a consolidated effort.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
