Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems. The DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and/or timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
55
-Determines serum enzymatic activity of TK1
-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGAny physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value
Time frame: Within the first 48-week period of study participation
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Time frame: At 12 weeks
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Time frame: At 12 weeks and 24 weeks
Number of surveillance imaging tests intended to be used and actually used, in total and by modality
Time frame: Over the entire study period (estimated to be 36 months)
Longitudinal changes in DiviTum® TKa value dynamics
The TK trajectory of a patients will be plot against time for temporal pattern and the trajectories will be modeled via linear or non-linear mixed effects mode as appropriate. If linear mixed effects model, the longitudinal rate of change will be estimated with 95% CI to indicate growth rate of TK. If non-linear, the regression coefficients of time or time relevant terms will be estimated with 95% CI
Time frame: Over the entire study period (estimated to be 36 months)
Cohort 1 only: DiviTum® TKa level
Time frame: At 2 weeks post CDK 4/6 inhibitor therapy initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.