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.
PRIMARY OBJECTIVE: I. To evaluate the median percent change from baseline (prior to the start of an aromatase inhibitor \[AI\]) at 15 months in C-terminal telopeptide of type 1 collagen (CTx) in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline. SECONDARY OBJECTIVES: I. To evaluate the median percent change from baseline (prior to the start of an AI) at 15 months in the lumbar spine and hip bone mineral density in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline. II. To evaluate safety and risk of fracture associated with WBF-038. EXPLORATORY OBJECTIVES: I. To evaluate changes from baseline (prior to the start of an AI) over time in CTx, alkaline phosphatase (ALK), fasting blood sugar (FBS), hemoglobin A1C (HbA1C), and Procollagen I Intact N-Terminal (P1NP) at 3, 6, 15, and 18 months post-baseline. II. To evaluate changes from baseline (prior to the start of an AI) over time in weight and waist circumference at 3, 6, 15, and 18 months post-baseline. III. To evaluate changes in the cytokine profile over time. IV. To evaluate the association between stool microbiome, stool short-chain fatty acid (SCFA), and serum SCFA and changes over time in CTx and lumbar spine and hip bone mineral density. V. To evaluate changes over time in AI-associated musculoskeletal symptoms (AIMSS) with patient-reported outcomes (PRO) using the Stanford Health Assessment Questionnaire (HAQ) and pain visual analog scale (VAS). OUTLINE: Patients receive WBF-038 orally (PO) once daily (QD) for 365 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and bone mineral density (BMD) test at screening and on study. After completion of study intervention, patients are followed up at 90 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
38
Undergo blood sample collection
Undergo BMD
Ancillary studies
Given WBF-038 PO
Mayo Clinic in Florida
Jacksonville, Florida, United States
RECRUITINGChange in C-terminal telopeptide of type 1 collagen (CTx)
Assessed by standard lab tests at baseline (at study enrollment/eligibility assessment before any therapy) followed by 6 study visits. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Time frame: Baseline; 90 days after start of AI therapy (before beginning WBF-038); 14 days after start of WBF-038; 90 days after start of WBF-038; 180 days after start of WBF-038; 365 days after start of WBF-038; 90 days after stopping WBF-038
Change in lumbar spine mineral density
Will be measured by central dual energy x-ray absorptiometry. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Time frame: Baseline; 365 days after start of WBF-038
Change in hip bone mineral density
Will be measured by central dual energy x-ray absorptiometry. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Time frame: Baseline; 365 days after start of WBF-038
Incidence of adverse events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Baseline; 90 days after start of AI therapy (before beginning WBF-038); 90 days after start of WBF-038; 365 days after starting WBF-038; 90 days after stopping WBF-038;
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.