Actively Recruiting
Phase 2 Study of a 5-Strain Probiotic to Prevent Bone Loss in Women with Early-Stage Hormone Receptor-Positive Breast Cancer Starting Aromatase Inhibitor Therapy
Led by Mayo Clinic · Updated on 2026-08-10
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a probiotic called WBF-038 in patients with early-stage hormone receptor-positive breast cancer who are beginning treatment with aromatase inhibitors. Aromatase inhibitors reduce estrogen production to help prevent cancer growth but can negatively impact bone health, weight, blood sugar, and waist size. This Phase II trial aims to see if WBF-038 can help prevent bone loss and improve metabolic health during this treatment. Participants receive WBF-038 by mouth once daily for 365 days, starting three months after beginning aromatase inhibitor therapy, unless disease progression or unacceptable side effects occur. During the study, patients undergo blood sample collections and bone mineral density tests at screening and various points throughout the trial. After completing the year of probiotic treatment, participants are followed up for 90 days. Throughout the study, researchers measure changes in bone turnover markers, bone mineral density in the lumbar spine and hips, blood sugar levels, weight, waist circumference, and inflammatory markers. Patient-reported symptoms related to aromatase inhibitor treatment are also assessed. Safety and fracture risk are monitored by tracking adverse events. The total participation is approximately 18 months from baseline to final follow-up.
CONDITIONS
Brief Title
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Histologically confirmed anatomical stage 0 to III hormone receptor-positive breast cancer
- Planning to start treatment with an aromatase inhibitor (letrozole, anastrozole, or exemestane) with or without ovarian function suppression
- Absolute neutrophil count (ANC) of at least 1000/mm^3 before registration
- Platelet count of at least 75,000/mm^3 before registration
- Hemoglobin level of at least 9.0 g/dL before registration
- Creatinine level no more than twice the upper limit of normal before registration
- Serum glutamic-oxaloacetic transaminase (AST) no more than twice the upper limit of normal before registration
- Albumin level of at least 3 g/dL before registration
- Willing and able to provide research stool and blood samples
- Negative serum pregnancy test within 7 days before registration for women under 60 with an intact uterus
- Capable of providing informed consent
- Willing to return to the enrolling institution for all study visits
You will not qualify if you...
- Requires prolonged systemic antibiotic therapy or has taken systemic antibiotics within 14 days before registration
- Received fecal microbiota transplant (FMT) within 6 months before registration
- Experienced serious adverse events related to FMT
- Has systemic illnesses or severe concurrent diseases making participation unsafe or assessment difficult
- Immunocompromised, including HIV positive or on chronic steroids over 20 mg prednisone daily within 90 days prior to registration
- History of inflammatory bowel disease, chronic diarrhea, or celiac disease
- Currently has a colostomy
- Had intraabdominal gastrointestinal surgery within 60 days before registration
- Evidence of active, severe colitis
- History of short gut syndrome or motility disorders
- Requires daily medications for bowel hypermotility
- Active autoimmune disease requiring systemic treatment within 30 days prior to registration
- History of osteoporosis, hyperparathyroidism, or untreated vitamin D deficiency
- Receiving or will receive bisphosphonates or denosumab during the study period
- Received oral bisphosphonates within 12 weeks, IV zoledronic acid within 52 weeks, or denosumab within 24 weeks
- Known hypersensitivity to any component of the study product or certain antibiotics
- Received an experimental product within 30 days before registration
- Receiving or will receive CDK 4/6 inhibitors
- Received chemotherapy within 30 days before registration
Research Team
C
Clinical Trials Referral Office
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