Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing

Recruiting N/A Interventional Study
Breast Cancer Cancer of the Breast
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
55 (estimated)
Sponsor
Washington University School of Medicine · Other
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About This Trial
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 activit…
Trial Locations
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Eligibility Criteria
Inclusion Criteria - Patients: * 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. * Cohort 1 only: Scheduled to initiate…
Contacts

Nusayba Bagegni, M.D.

314-273-3022

nbagegni@wustl.edu

CONTACT