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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Given PO
Mayo Clinic in Florida
Jacksonville, Florida, United States
Incidence of adverse events
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 adverse events.
Time frame: Up to 4 weeks prior to surgery
Systemic immunomodulatory effects
The percent change in plasma concentrations of interleukin (IL)-1beta, 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. will be summarized as mean (standard deviation) or median (range) where appropriate. Each of these factors will be plotted against time with the points belonging to a particular individual connected. Each graph will be visually inspected for trends across time and difference between treatment regimens. For each marker, the number of patients with at least a 2-fold increase/decrease in the number of cells/plasma concentration (marker specific response) after the first cycle of treatment as well as anytime during treatment will be determined.
Time frame: Up t0 6 months after treatment
Engraftment rate
Time frame: Up to 6 months after treatment
Durability of bacterial engraftment of RBX7455
Will be evaluated with bacterial taxonomy using provided stool samples obtained by patient.
Time frame: Up to 6 months after treatment
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