RecruitingPhase 2NCT07044310

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


Sponsor

Mayo Clinic

Enrollment

38 participants

Start Date

Jul 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a 5-strain probiotic supplement can help prevent bone loss in women with hormone receptor-positive breast cancer who are starting aromatase inhibitor therapy. Aromatase inhibitors lower estrogen levels, which can weaken bones over time. The study explores whether improving gut bacteria can protect bone density during this treatment. **You may be eligible if...** - You are a woman 18 or older - You have been diagnosed with hormone receptor-positive breast cancer, stage 0–3, confirmed by biopsy - You are about to start taking an aromatase inhibitor (letrozole, anastrozole, or exemestane), with or without ovarian function suppression - Your blood counts and kidney function meet the required levels **You may NOT be eligible if...** - You have already started aromatase inhibitor therapy - You have already lost significant bone density (osteoporosis with a T-score below a certain threshold) - You are taking bone-strengthening medications (bisphosphonates or denosumab) - You have immune conditions or recent serious infections that make probiotics unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Mineral Density Test

Undergo BMD

OTHERQuestionnaire Administration

Ancillary studies

DRUGWBF-038

Given WBF-038 PO


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT07044310


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