Actively Recruiting
5-strain Probiotic Formulation in HR-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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- 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) with or without ovarian function suppression as decided by physician
- Absolute neutrophil count (ANC) of 1000/mm^3 or higher before registration
- Platelet count of 75,000/mm^3 or higher before registration
- Hemoglobin level of 9.0 g/dL or higher before registration
- Creatinine level less than or equal to twice the upper limit of normal before registration
- Serum glutamic-oxaloacetic transaminase (AST) less than or equal to twice the upper limit of normal before registration
- Albumin level 3 g/dL or higher before registration
- Willing and able to provide stool and blood samples for research
- Negative pregnancy test within 7 days before registration for women of childbearing potential under 60 with intact uterus
- Able to give informed consent
- Willing to return for all study visits including blood draws
You will not qualify if you...
- Requires long-term systemic antibiotic therapy or recent systemic antibiotic use within 14 days before registration
- Fecal microbiota transplant (FMT) within 6 months before registration
- FMT with serious adverse event related to the procedure
- Severe systemic illnesses or diseases that interfere with safety assessment of probiotics
- Immunocompromised status including HIV positive or on chronic steroids over 20 mg prednisone daily unless off steroids for 90 days
- History of inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or microscopic colitis
- History of chronic diarrhea or celiac disease
- Current colostomy
- Abdominal surgery related to gastrointestinal tract within 60 days before registration
- Active, severe colitis
- History of short gut syndrome or motility disorders
- Daily use of medications for bowel hypermotility such as imodium or lomotil
- Active autoimmune disease requiring systemic treatment within 30 days before registration
- History of osteoporosis or hyperparathyroidism
- Untreated vitamin D deficiency
- Receiving or will receive bisphosphonates or denosumab during study
- Recent oral bisphosphonate within 12 weeks, IV zoledronic acid within 52 weeks, or denosumab within 24 weeks
- Known allergy to study product components or related antibiotics
- Received experimental products within 30 days before registration
- Receiving or will receive CDK 4/6 inhibitors
- Received chemotherapy within 30 days before registration
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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