DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment

To prospectively evaluate the efficacy and safety of DPYD-guided dosing strategies in a real-world clinical setting, specifically by comparing the incidence of severe (Grade 3 and 4) fluoropyrimidine-related toxicities of heterozygous DPYD variant patients assigned to DPYD-guided reduced dosing versus patients with standard dosing in the control arm.

Trial Details

NCT ID
NCT07158164
Phase
PHASE4
Sponsor
Rutgers, The State University of New Jersey
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Fluorouracil injection
  • Xeloda
Locations (sample)
  • Belleville, New Jersey, United States
  • Elizabeth, New Jersey, United States
  • Hamilton, New Jersey, United States
  • Jersey City, New Jersey, United States
  • Livingston, New Jersey, United States

Key Eligibility Criteria

  • Diagnosis of cancer in either the adjuvant or metastatic setting requiring initial therapy with 5-FU or Capecitabine.
  • DPYD testing performed by a CLIA-certified laboratory (i.e., Guardant 360 or Caris blood testing for genomic profiling, DPYD testing by the Mayo Cl…
  • DPYD testing results falling into one of the following cohorts for first-line therapy with a fluoropyridine:
  • Study Cohort: Patients with one DPYD variant in one gene (heterozygotes).

For full eligibility, visit ClinicalTrials.gov.

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