Trials / Recruiting

RecruitingNCT07044310

5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 38 (estimated)

Sponsor: Mayo Clinic · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Bone Mineral Density Test	Undergo BMD
OTHER	Questionnaire Administration	Ancillary studies
DRUG	WBF-038	Given WBF-038 PO

Timeline

Start date: 2025-07-25
Primary completion: 2027-07-25
Completion: 2027-07-25
First posted: 2025-06-29
Last updated: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07044310. Inclusion in this directory is not an endorsement.