5-strain probiotic to prevent bone loss during aromatase inhibitor therapy
Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
This trial will try a 5-strain probiotic called WBF-038 to see if it prevents bone loss in people with early-stage hormone receptor–positive breast cancer who are starting aromatase inhibitor therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | denosumab, chemotherapy, prednisone |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT07044310 on ClinicalTrials.gov |
What this trial studies
This is a phase II trial testing WBF-038, a combined prebiotic–probiotic formulation, in patients with early-stage hormone receptor–positive breast cancer who begin aromatase inhibitor therapy. Participants start the probiotic 3 months after baseline and receive it for 12 months, with primary measurement of change in the bone turnover marker CTx at 15 months and secondary measurement of lumbar spine and hip bone mineral density. The study includes bone density scans, blood and stool biospecimen collection, and patient questionnaires to track musculoskeletal symptoms, metabolic markers, and microbiome changes. Safety and fracture risk are monitored and several exploratory analyses will examine associations between stool/serum short-chain fatty acids, cytokines, and bone health over time.
Who should consider this trial
Good fit: Women aged 18 or older with stage 0–III hormone receptor–positive breast cancer who are about to start an aromatase inhibitor (with or without ovarian suppression), have ECOG 0–2, meet routine lab limits, and are willing to provide blood and stool samples.
Not a fit: Patients not starting an aromatase inhibitor, those with metastatic disease, those already receiving bone-active treatments (such as bisphosphonates or denosumab), or those with significant pre-existing bone disease may be unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, WBF-038 could help preserve bone strength and improve metabolic markers during aromatase inhibitor therapy, potentially lowering fracture risk and some treatment-related side effects.
How similar studies have performed: Small clinical and preclinical studies of probiotic or synbiotic approaches have suggested benefits for bone turnover and metabolic health, but evidence specifically in patients on aromatase inhibitors is limited and this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer * Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovarian function suppression (OFS) per treating physician's discretion * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (prior to registration) * Platelet count ≥ 75,000/mm\^3 (prior to registration) * Hemoglobin ≥ 9.0 g/dL (prior to registration) * Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration) * Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) ≤ 2 x ULN (prior to registration) * Albumin ≥ 3 g/dL (prior to registration) * Willing and able to provide research stool and blood samples * Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\< 60 years old with intact uterus) * Capable of providing valid informed consent * Willing to return to enrolling institution for all study visits (blood draws, etc) Exclusion Criteria: * Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration * Fecal microbiota transplant (FMT) ≤ 6 months prior to registration * FMT with an associated serious adverse event related to the FMT product or procedure * 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 * 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 * History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis * History of chronic diarrhea * History of celiac disease * Currently has a colostomy * Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration * Evidence of active, severe colitis * History of short gut syndrome or motility disorders * Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil * 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 * History of osteoporosis or hyperparathyroidism * History of untreated vitamin D deficiency * Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab * Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded * Known hypersensitivity to any component of study product (including known inulin intolerance) * Known hypersensitivity to \> 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin * Known hypersensitivity to \> 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin * Received an experimental product ≤ 30 days prior to registration * Receiving or will receive CDK 4/6 inhibitor (abemaciclib, ribociclib, or palbociclib) * Received chemotherapy ≤ 30 days prior to registration
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Saranya Chumsri, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.