A Study to Evaluate Preoperative Oral Microbiota-Based Investigational New Drug to Target Immune Response in Patients with Operable Stage I-III Breast Cancer
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Jacksonville, Florida: 19-004024
NCT ID: NCT04139993
Sponsor Protocol Number: RBX7455
About this study
The primary purposes of this trial are to determine the safety and tolerability of RBX7455 given for at least 2 weeks and not more than 4 weeks prior to surgery, and to evaluate intratumoral immune system resonse, including TILs, CD4, and CD8 T cells, in operable breast cancer patients.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Female age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Histologically confirmed un-resected operable invasive adenocarcinoma of the breast ≥ 0.5 cm.
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 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.
- Patients must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1000/mm^3;
- Platelet count ≥ 75,000/mm^3;
- Hemoglobin ≥ 9.0 g/dL;
- Creatinine ≤ 2 x ULN;
- SGOT (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 purpose.
- Agrees not to take non-dietary probiotics through 8 weeks after receiving the course of study drug (including OTC and prescription).
- Agrees not to take any oral vancomycin, metronidazole, fidaxomicin, rifaximin, nitazoxanide, bezlotoxumab and 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.
- 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 regimens.
- Immunocompromised patients including patients known to be 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.
- 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.
- Breast feeding.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Maria Vazquez Roque, M.D., M.S.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available