RECRUITING

5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

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Conditions

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Hormone Receptor-Positive Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests how well a probiotic, WBF-038, works in preventing bone loss in patients with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors are a drug that blocks the activity of an enzyme called aromatase, which the body uses to make estrogen in the ovaries and other tissues. Blocking aromatase lowers the amount of estrogen made by the body, which may stop the growth of cancer cells that need estrogen to grow. Aromatase inhibitors are used to treat some types of breast cancer or to keep it from coming back. Aromatase inhibitors can affect bone health, weight, blood sugar, and waist size. WBF-038 is a combination of both prebiotics and probiotics, designed to improve metabolic health. Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive breast cancer starting on adjuvant endocrine therapy with an aromatase inhibitor.

Official Title

Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

Quick Facts

Study Start:2025-07-25
Study Completion:2027-07-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07044310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female age ≥ 18 years
  2. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  3. * Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer
  4. * Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion
  5. * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (prior to registration)
  6. * Platelet count ≥ 75,000/mm\^3 (prior to registration)
  7. * Hemoglobin ≥ 9.0 g/dL (prior to registration)
  8. * Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)
  9. * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) ≤ 2 x ULN (prior to registration)
  10. * Albumin ≥ 3 g/dL (prior to registration)
  11. * Willing and able to provide research stool and blood samples
  12. * Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\< 60 years old with intact uterus)
  13. * Capable of providing valid informed consent
  14. * Willing to return to enrolling institution for all study visits (blood draws, etc)
  1. * Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration
  2. * Fecal microbiota transplant (FMT) ≤ 6 months prior to registration
  3. * FMT with an associated serious adverse event related to the FMT product or procedure
  4. * Co-morbid systemic illnesses or other severe concurrent diseases 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 over-the-counter probiotics
  5. * 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 ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted
  6. * History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
  7. * History of chronic diarrhea
  8. * History of celiac disease
  9. * Currently has a colostomy
  10. * Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration
  11. * Evidence of active, severe colitis
  12. * History of short gut syndrome or motility disorders
  13. * Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil
  14. * Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. 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 ≤ 30 days prior to registration are not excluded
  15. * History of osteoporosis or hyperparathyroidism
  16. * History of untreated vitamin D deficiency
  17. * Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab
  18. * Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded
  19. * Known hypersensitivity to any component of study product (including known inulin intolerance)
  20. * Known hypersensitivity to \> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin
  21. * Known hypersensitivity to \> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin
  22. * Received an experimental product ≤ 30 days prior to registration
  23. * Receiving or will receive CDK 4/6 inhibitor (abemaciclib, ribociclib, or palbociclib)
  24. * Received chemotherapy ≤ 30 days prior to registration

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Saranya Chumsri, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Saranya Chumsri, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25
Study Completion Date2027-07-25

Study Record Updates

Study Start Date2025-07-25
Study Completion Date2027-07-25

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage 0 Breast Cancer AJCC v8
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Hormone Receptor-Positive Breast Carcinoma