The study hypothesis is that incorporation of data from DiviTum®TKa measurements into the treatment monitoring of patients receiving standard first line treatment with CDK 4/6 inhibitors plus endocrine therapies, will be associated with the physicians’ decision to change usage and/or timing of other routine monitoring tests such as CT scans and nuclear medicine exams. The study will examine care over time of 55 patients that will be tested regularly with DiviTum®TKa.

“We are proud to support the TK IMPACT study which is a key step forward in the development of DiviTum®TKa as it examines the clinical utility of the test on actual care of metastatic breast cancer patients. Our vision is to change the standard of care in monitoring to easy, fast and safe blood-based TKa testing”, said Biovica’s CEO Anders Rylander.

“An increasing number of our patients with metastatic breast cancer go for many months, even years, without their disease progressing. Nonetheless, as today’s standard practice, we often bring them in for repeat imaging exams every three months. This is a burden on the patients. We believe that a convenient blood-based test will enable us to make changes that improve our patients’ lives. We are excited to test our ability to make changes in this study” said Dr Nusayba Bagegni, the principal investigator of the study.
 
Earlier studies have demonstrated that patients with low TKa levels have extended times to disease progression, which enables the possibility to modify and reduce usage of other monitoring exams such as imaging. These other exams represent a burden both on patients and on healthcare costs.

To provide patients, their families, healthcare professionals, and the public with the information about the clinical trial, the TK IMPACT study is listed on the ClinicalTrials.gov website: (https://clinicaltrials.gov/ct2/show/NCT04968964?term=Bagegni&draw=2&rank=1)