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

NCT07044310 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

  • Anatomic Stage 0 Breast Cancer AJCC v8
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Hormone Receptor-Positive Breast Carcinoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Saranya Chumsri, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2027-07-25
Completion
2027-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044310 on ClinicalTrials.gov