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.
Patients
Arm 1: Patient must be planning to initiate standard of care first-line therapy with FDA-approved endocrine therapy plus CDK4/6 inhibitor for the stated diagnosis at the time of study enrollment. Note: Ribociclib is the preferred CDK4/6 inhibitor, but alternative CDK4/6 inhibitors are allowed. Note: Initiation of endocrine therapy prior to ultimate plan for addition of CDK4/6 inhibitor is permitted prior to enrollment.
Arm 2: patient must be planning to initiate standard of care second-line therapy with FDA-approved endocrine therapy plus CDK4/6 inhibitor for the stated diagnosis at the time of study enrollment. Triplet regimens are permitted as long as they contain CDK4/6 inhibitor and endocrine therapy. Note: Initiation of endocrine therapy prior to ultimate plan for addition of CDK4/6 inhibitor is permitted prior to enrollment.
Arm 3: patient must be planning to initiate first- or second-line therapy for the stated diagnosis at the time of study enrollment with therapy other than endocrine therapy plus CDK4/6 inhibitor.
Patients
Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limit to chemotherapy use in the neoadjuvant or adjuvant setting.
Prior or concurrent malignancy (unless that malignancy's natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen).
Arms 1 and 2: Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.
Parallel
DiviTum® TKa assay
DeviceWill be utilized for determination of serum enzymatic activity of TK1 according to the manufacturer's instructions
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Treatment groupsSee each treatment group below.
Progression-free survival (PFS) in patients who remain on CKD4/6i (Arms 1 and 2, Cohort A)
PFS is defined as from the start date of receiving CDK4/6i to the date of progression, death, or last follow-up.
Clinical benefit rate (CBR) in patients who remain on CDK4/6i (Arms 1 and 2, Cohort A)
CBR is defined as total number (or percentage) of patients who achieved a complete response, partial response, or had stable disease for 6 months or more.
Progression-free survival (PFS2) in patients who switch to an alternate therapy (Arms 1 and 2, Cohort B)
PFS is defined as from the start date of receiving CDK4/6i to the date of progression on the alternate therapy, death, or last follow-up.
Clinical benefit rate (CBR) in patients who switch to an alternate therapy (Arms 1 and 2, Cohort B)
CBR is defined as total number (or percentage) of patients who achieved a complete response, partial response, or had stable disease for 6 months or more.
Feasibility of early therapeutic switching as measured by compliance rate (Arms 1 and 2, Cohorts B and C)
Compliance is defined as subset of physicians and patients following protocol recommendation to switch to next line of treatment
Feasibility of delayed imaging as measured by compliance rate (Arm 1 Cohort A)
Compliance is defined as this subset of physicians and patients who delay restaging scans from C7D1 to C10D1.
Baseline TKa levels to predict clinical benefit on first-line CDK4/6i and on later lines of therapy (All Arms and Cohorts)
Clinical benefit is defined as SD for 16 weeks or longer, CR, or PR.
Cycle 1 day 15 TKa levels to predict clinical benefit on first-line CDK4/6i and on later lines of therapy (All Arms and Cohorts)
Clinical benefit is defined as SD for 16 weeks or longer, CR, or PR.
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Washington University School of Medicine
Lead sponsor
Biovica
Collaborator
