Anatomic Stage I Breast Cancer AJCC v8Phase 1NCT04139993
RBX7455 Before Surgery for the Treatment of Operable Breast Cancer
A Phase 1 study testing Microbiota-based Formulation RBX7455 in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Microbiota-based Formulation RBX7455
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 11 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Agrees not to take non-dietary probiotics through 8 weeks after receiving the course of study drug (including over-the counter [OTC] and prescription)
- Agrees not to take any oral vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide, bezlotoxumab and intravenous immunoglobulin therapy (IVIG) through the 8-week follow-up assessment unless newly prescribed by a treating investigator during the course of the study
- Willing to employ adequate contraception from the time of enrollment through 3 months after the final dose of RBX7455
- Note: Adequate contraception methods include birth control pills, barrier device, intrauterine device
- Capable of understanding the investigative nature, potential risks, and benefits of the study
- Capable of providing valid informed consent
- Willing to return to enrolling institution for all study visits (blood draws, etc)
- Willing and able to complete the required Patient Medication Diary
- Willing and able to meet all study requirements, including attending all assessment visits and telephone calls
- Women of child bearing potential must have negative pregnancy test within 7 days of enrollment
Who cannot join
- 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
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- 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
- Requires the regular use of medications to manage bowel hypermotility
- Active autoimmune disease that has required systemic treatment in the =< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to randomization. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Microbiota-based Formulation RBX7455
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota-based Formulation RBX7455Drug
Also called RBX 7455, RBX-7455, RBX7455
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (RBX7455) | Experimental | 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. Receives: Drug: Microbiota-based Formulation RBX7455 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks prior to surgery
Secondary outcomes (3)
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.
Measured: Up t0 6 months after treatment
Engraftment rate
Measured: 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.
Measured: Up to 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start31 Aug 2020
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria I Vazquez Roque, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139993
- Sponsor's protocol ID
- 19-004024
- Other IDs
- NCI-2021-02748, 19-004024
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04139993
- Acronym / sponsor ID
- 19-004024
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (RBX7455) | Experimental | Drug: Microbiota-based Formulation RBX7455Prior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Histologically confirmed un-resected operable invasive adenocarcinoma of the breast >= 0.5cm
- Patients must not receive neoadjuvant chemotherapy prior to surgery
- Absolute neutrophil count (ANC) >= 1000/mm^3
- Platelet count >= 75,000/mm^3
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota-based Formulation RBX7455Also: RBX 7455, RBX-7455, RBX7455Given PO | Drug | Treatment (RBX7455) |
Primary outcome
Incidence of adverse events
Time frame: Up to 4 weeks prior to surgery
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.
3 secondary outcomes
Systemic immunomodulatory effects
Time frame: Up t0 6 months after treatment
Engraftment rate
Time frame: Up to 6 months after treatment
Durability of bacterial engraftment of RBX7455
Time frame: Up to 6 months after treatment
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria I Vazquez Roque principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microbiota-based Formulation RBX7455 in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 4 weeks prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.