A Study to Evaluate Preoperative Oral Microbiota-Based Investigational New Drug to Target Immune Response in Patients with Operable Stage I-III Breast Cancer

Overview

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.

Participation eligibility

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • 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 or endocrine therapy 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 purposes.
  • 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.
  • Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Willing to employ adequate contraception from the time of registration 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 Subject Diary.
  • Willing and able to meet all study requirements, including attending all assessment visits and telephone calls.

Exclusion Criteria:

  • 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 registration. 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 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.
  • Known history of autoimmune disease, including Type I diabetes.

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 Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Maria Vazquez Roque, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions