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NCT07158164 · ClinicalTrials.gov registry record · Phase 4
DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment
A Phase 4 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 12
- Study locations
NCT07158164: Recruiting Phase 4 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Rutgers, The State University of New Jersey.
NCT07158164 is a Phase 4 study of Breast Neoplasms and Colorectal Neoplasms that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 100 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower). The trial reports 12 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07158164, a Phase 4 study of Breast Neoplasms and Colorectal Neoplasms, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Primary Outcome
Number and proportion of patients experiencing Grade 3, 4, or 5 toxicities related to 5-FU or Capecitabine, as defined by CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Xeloda
- DRUG Fluorouracil injection
Study Locations (12)
New Jersey
- RWJBarnabas Health Clara Maas Medical Center - Belleville
- Trinitas Hospital and Comprehensive Cancer Center - Elizabeth
- RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton - Hamilton
- RWJBarnabas Health Jersey City Medical Center - Jersey City
- Cooperman Barnabas Medical Center - Livingston
- Jack and Sheryl Morris Cancer Center - New Brunswick
- RWJBarnabas Health - Robert Wood Johnson University Hospita - New Brunswick
- Cancer Center Initiative - Newark
- University Hospital - Newark
- RWJBarnabas Health Newark Beth Israel Medical Center - Newark
- RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset - Somerville
- RWJBarnabas Health - Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-08-27 |
| Est. Completion | 2029-07-07 |
| Phase | Phase 4 |
What NCT07158164 shows while recruiting
NCT07158164 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Xeloda is the first listed.
NCT07158164 lists 12 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT07158164 about?
NCT07158164 is a clinical study titled "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 vers...
What is the current status of trial NCT07158164?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-08-27. Estimated completion is 2029-07-07.
What conditions does trial NCT07158164 study?
This clinical trial studies the following conditions: Breast Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Gastro-Intestinal Intraepithelial Neoplasia.
What interventions are being tested in trial NCT07158164?
The interventions under investigation include: Xeloda (DRUG), Fluorouracil injection (DRUG).
Who is sponsoring clinical trial NCT07158164?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07158164 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07158164's enrollment target sits among peer trials
100 55th of 97 higher than 40 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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