Clinical Trials Directory

Trials / Terminated

TerminatedNCT04139993

RBX7455 Before Surgery for the Treatment of Operable Breast Cancer

A Pilot Trial of Preoperative Oral Microbiota-Based Investigational New Drug, RBX7455 to Target Immune Response in Patients With Operable Stage I-III Breast Cancer

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of microbiota-based formulation RBX7455 (RBX7455) given for at least 2 weeks and not more than 4 weeks prior to surgery. II. To evaluate intratumoral immunomodulatory effects, including tumor infiltrating lymphocytes ( TILs), CD4, and CD8 T cells, in operable breast cancer patients. SECONDARY OBJECTIVES: I. To evaluate systemic immunomodulatory effects of RBX7455 by measuring circulating cytokines including IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, CXCL8 (IL-8), IL-10, IL-12, IL-13, IL- 17A, IFN-gamma, TNF-alpha, CCL2 (MCP-1), CCL4 (MIP-1beta), granulocyte-colony stimulating factor (G-CSF), and granulocyte macrophage (GM)-CSF before and after treatment with RBX7455. II. To assess stool microbiome α-diversity, bacterial abundance, and bacterial taxonomy before and after treatment with RBX7455. III. To assess the durability of bacterial engraftment of RBX7455 in the stool at 8 weeks and 6 months. OUTLINE: 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. After completion of surgery, patients are followed up at 8 weeks and 6 months.

Conditions

Interventions

TypeNameDescription
DRUGMicrobiota-based Formulation RBX7455Given PO

Timeline

Start date
2020-08-31
Primary completion
2023-01-11
Completion
2023-01-11
First posted
2019-10-25
Last updated
2023-10-04

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04139993. Inclusion in this directory is not an endorsement.

RBX7455 Before Surgery for the Treatment of Operable Breast Cancer (NCT04139993) · Clinical Trials Directory