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Life sciences · Interventional Study
ClinicalTrials.gov · October 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05977036). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 145 participants (ESTIMATED). Conditions: Metastatic Breast Cancer, Unresectable Breast Cancer. Interventions: DEVICE: DiviTum® TKa assay. Primary outcome measures: Progression-free survival (PFS) in patients who remain on CKD4/6i (Arms 1 and 2, Cohort A) , Through completion of follow-up (estimated to be 7 years); Clinical benefit rate (CBR) in patients who remain on CDK4/6i (Arms 1 and 2, Cohort A) , Through completion of follow-up (estimated to be 7 years); Progression-free survival (PFS2) in patients who switch to an alternate therapy (Arms 1 and 2, Cohort B) , Through completion of follow-up (estimated to be 7 years); Clinical benefit rate (CBR) in patients who switch to an alternate therapy (Arms 1 and 2, Cohort B) , Through completion of follow-up (estimated to be 7 years). Brief summary: This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with hormone receptor (HR) positive, HER-2 negative metastatic or unresectable breast cancer receiving first-line or second-line treatment.