Study Stopped
poor accrual
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
2 other identifiers
interventional
3
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 25, 2019
CompletedStudy Start
First participant enrolled
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2023
CompletedOctober 4, 2023
October 1, 2023
2.4 years
October 22, 2019
October 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 4 weeks prior to surgery
Secondary Outcomes (3)
Systemic immunomodulatory effects
Up t0 6 months after treatment
Engraftment rate
Up to 6 months after treatment
Durability of bacterial engraftment of RBX7455
Up to 6 months after treatment
Study Arms (1)
Treatment (RBX7455)
EXPERIMENTALPrior 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.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Histologically confirmed un-resected operable invasive adenocarcinoma of the breast \>= 0.5cm
- For cohort 1: Estrogen receptor (ER) and/or progesterone receptor (PR) positive \>= 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression
- For cohort 2: Human epidermal growth factor receptor 2 (HER2) amplification with fluorescence in situ hybridization (FISH) ratio \>= 2.0 or overexpression by immunohistochemistry 3+ with any ER and/or PR
- For cohort 3: Triple negative. Estrogen receptor (ER) and/or progesterone receptor (PR) negative \< 10%, and no human epidermal growth factor receptor 2 (HER2) amplification or overexpression
- Patients must not receive neoadjuvant chemotherapy prior to surgery
- Absolute neutrophil count (ANC) \>= 1000/mm\^3
- Platelet count \>= 75,000/mm\^3
- Hemoglobin \>= 9.0 g/dL
- Creatinine =\< 2 x upper limit of normal (ULN)
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2 x ULN
- Albumin \>= 3 g/dL
- Willing and able to swallow capsules
- Willing and able to complete the stool and serum testing required for the study
- Willing to provide blood samples for correlative research purposes
- +10 more criteria
You may not qualify if:
- Requires systemic antibiotic therapy for other condition
- Fecal microbiota transplant (FMT) within the past 6 months
- FMT with an associated serious adverse event related to the FMT product or procedure
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimen
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive or those on chronic steroids \> 20 mg prednisone a day or prednisone-equivalent
- Note: Must be off systemic steroids at least 90 days prior to enrollment. However, topical steroids, inhalants or steroid eye drops are permitted
- Receiving any other investigational agent
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
- Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria
- History of chronic diarrhea
- History of celiac disease
- Currently has a colostomy
- Intraabdominal surgery related to gastrointestinal tract within the last 60 days
- Evidence of active, severe colitis
- History of short gut syndrome or motility disorders
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria I Vazquez Roque
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2019
First Posted
October 25, 2019
Study Start
August 31, 2020
Primary Completion
January 11, 2023
Study Completion
January 11, 2023
Last Updated
October 4, 2023
Record last verified: 2023-10