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.
Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.
Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR
Patients initiated endocrine therapy alone with ultimate intention to add CDK 4/6 inhibitor therapy, OR
Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4/6 inhibitor. Patients may have also received CDK 4/6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.
Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating physician and with agreement by Principal Investigator
Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.
Medical Oncologist at Siteman Cancer Center
Parallel
DiviTum® TKa assay
Device-Determines serum enzymatic activity of TK1
Study Care Plans
Other intervention-Study Care Plans will be completed prior to and post release of serum DiviTum® TKa value
Any physician-reported intended change in imaging testing interval identified on the study care plan post receipt of DiviTUM® TKa value
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Concordance rate between progression status on the first on-study imaging and progression status based on DiviTum® TKa values
Number of surveillance imaging tests intended to be used and actually used, in total and by modality
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
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Washington University School of Medicine
Lead sponsor
Biovica
Collaborator
