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NCT04139993 · ClinicalTrials.gov registry record · Phase 1
RBX7455 Before Surgery for the Treatment of Operable Breast Cancer
A Phase 1 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT04139993: Clinical Trial Phase 1 study, sponsored by Mayo Clinic.
NCT04139993 is a Phase 1 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04139993, a Phase 1 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This clinical trial studies the side effects and possible benefits of RBX7455 given before surgery in treating patients with breast cancer that can be removed by surgery (operable). RBX7455 contains live intestinal microbes (active drug), which are obtained from healthy human stool and may restore the normal balance of microorganisms in the intestines through the transplant of live and beneficial microorganisms.
Primary Outcome
Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency (percentage) of toxicity for all patients will be reported by study statistician and reviewed by primary disease site to determine toxicity patterns. Evaluation of RBX7455 will be assessed by physical exams and laboratory testing with number of patients with abnormal laboratory values and adve
Interventions
- DRUG Microbiota-based Formulation RBX7455
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2023-01-11 |
| Phase | Phase 1 |
Why NCT04139993 stopped before completion
NCT04139993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Microbiota-based Formulation RBX7455 is the first listed.
NCT04139993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04139993 about?
NCT04139993 is a clinical study titled "RBX7455 Before Surgery for the Treatment of Operable Breast Cancer". This clinical trial studies the side effects and possible benefits of RBX7455 given before surgery in treating patients with breast cancer that can be removed by surgery (operable). RBX7455 contains live intestinal microbes (active drug), which are obtained from healthy human stool and may restore t...
What is the current status of trial NCT04139993?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2020-08-31. Estimated completion is 2023-01-11.
What interventions are being tested in trial NCT04139993?
The interventions under investigation include: Microbiota-based Formulation RBX7455 (DRUG).
Who is sponsoring clinical trial NCT04139993?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04139993's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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