Actively Recruiting
Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Led by Mayo Clinic · Updated on 2025-07-29
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a 5-strain probiotic formulation called WBF-038 in women with early-stage hormone receptor-positive breast cancer who are starting treatment with aromatase inhibitors. Aromatase inhibitors reduce estrogen production to help stop cancer cell growth but can negatively affect bone health, weight, and blood sugar. This phase II trial aims to see if WBF-038 can prevent bone loss and improve metabolic health during this treatment. Participants take WBF-038 orally once daily for one year, starting three months after beginning aromatase inhibitor therapy, unless disease progression or unacceptable side effects occur. The study includes blood sample collections and bone mineral density tests at screening and throughout the trial. After the treatment year, participants are followed for an additional 90 days. During the study, researchers measure changes in bone turnover markers like C-terminal telopeptide of type 1 collagen (CTx), lumbar spine and hip bone mineral density, blood sugar levels, weight, waist size, and musculoskeletal symptoms. Safety is closely monitored through adverse event tracking. Patient questionnaires and stool sample analyses are also used to explore metabolic and microbiome changes over time.
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 age 18 years or older
- ECOG performance status 0, 1, or 2
- Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer
- Planned start of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) with or without ovarian function suppression
- Absolute neutrophil count (ANC) of at least 1000/mm3 before registration
- Platelet count of at least 75,000/mm3 before registration
- Hemoglobin level of at least 9.0 g/dL before registration
- Creatinine within 2 times the upper limit of normal before registration
- Aspartate aminotransferase (AST) within 2 times 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 of childbearing potential
- Capable of providing informed consent
- Willing to return for all study visits
You will not qualify if you...
- Requires prolonged systemic antibiotic therapy or used systemic antibiotics within 14 days before registration
- Fecal microbiota transplant (FMT) within 6 months before registration
- History of serious adverse events related to FMT
- Severe concurrent diseases or systemic illnesses affecting safety assessment
- Immunocompromised status, including HIV or recent high-dose steroids
- History of inflammatory bowel disease, chronic diarrhea, or celiac disease
- Current colostomy
- Intraabdominal gastrointestinal surgery within 60 days before registration
- Active severe colitis
- History of short gut syndrome or motility disorders
- Daily use of medications for bowel hypermotility
- Active autoimmune disease requiring recent systemic treatment
- History of osteoporosis or hyperparathyroidism
- Untreated vitamin D deficiency
- Use or planned use of bisphosphonates or denosumab during the study
- Recent use of certain bisphosphonates or denosumab within specified timeframes
- Known hypersensitivity to study product components or related antimicrobial therapies
- Received experimental products within 30 days before registration
- Use or planned use of CDK 4/6 inhibitors
- Received chemotherapy within 30 days before registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 365 days
Participants receive the study drug WBF-038 orally once daily for 365 days in the absence of disease progression or unacceptable toxicity. Blood samples and bone mineral density tests are collected during this period to monitor changes and safety.
Multiple visits at baseline, 14 days, 90 days, 180 days, and 365 days during treatment
Duration - 90 days
After completing the treatment, participants are followed up for safety and outcome assessments.
1 visit (in-person) approximately 90 days after stopping treatment
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here