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Microbiota-based Therapy

Treatment (RBX7455) for Breast Cancer (RBX7455 Trial)

Phase 1
Waitlist Available
Led By Maria Vazquez Roque, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to swallow capsules
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after treatment
Awards & highlights

RBX7455 Trial Summary

This trial studies the side effects of RBX7455 before surgery in treating patients with operable breast cancer. RBX7455 contains live intestinal microbes, which may help to restore the normal balance of microorganisms in the intestines.

Eligible Conditions
  • Breast Cancer

RBX7455 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to swallow capsules and are willing to do so.

RBX7455 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Durability of bacterial engraftment of RBX7455
Engraftment rate
Systemic immunomodulatory effects

RBX7455 Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (RBX7455)Experimental Treatment1 Intervention
Prior to standard of care surgery, patients receive RBX7455 orally (PO) 4 days a week for 2-4 weeks in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,643 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,048 Total Patients Enrolled
83 Trials studying Breast Cancer
14,036 Patients Enrolled for Breast Cancer
Maria Vazquez Roque, MD, MSPrincipal InvestigatorMayo Clinic

Media Library

RBX7455 (Microbiota-based Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04139993 — Phase 1
Breast Cancer Research Study Groups: Treatment (RBX7455)
Breast Cancer Clinical Trial 2023: RBX7455 Highlights & Side Effects. Trial Name: NCT04139993 — Phase 1
RBX7455 (Microbiota-based Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04139993 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this research trial?

"Affirmative, the details published on clinicaltrials.gov illustrate that this medical trial is still recruiting participants. It was first made available to public review on August 31st 2020 and most recently updated on May 12th 2022 with a target of 30 patients across 2 research sites."

Answered by AI

Has RBX7455 been officially sanctioned by the Food and Drug Administration?

"Due to the limited evidence available for both safety and efficacy, our team at Power assigned RBX7455 a score of 1."

Answered by AI

Are new participants being recruited for this scientific experiment?

"Regulatory data on clinicaltrials.gov suggests that this medical trial is currently recruiting for participants. The study was first introduced to the public in August 2020 and has seen an update as recently as May 2022."

Answered by AI
~1 spots leftby Mar 2025