Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 7, 2026
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Phase 1 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT02608216). This is a study registration, not published results. Lead sponsor: University of Pennsylvania. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Breast Neoplasm, Metastatic Breast Cancer, Rb+ Breast Cancer. Interventions: DRUG: [18F]FLT; DEVICE: PET/CT; DRUG: ribociclib; DRUG: paclitaxel. Primary outcome measures: Measure changes in [18F]FLT uptake in metastatic tumors before and during treatment with ribociclib (LEE011) only, patient will have FLT PET/CT scan at baseline, run-in day -3, and cycle 1, day 1 of ribociclib (LEE011)/paclitaxel therapy , 4 years. Brief summary: In this study positron emission tomography (PET/CT) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluorothymidine (FLT).