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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07044310
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 25, 2025
Status verified
Jul 2025
Primary completion
Jul 25, 2027
Completion
Jul 25, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (WBF-038)
    Patients receive WBF-038 PO QD for 365 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and BMD test at screening and on study.

Primary Outcome Measure

Change in C-terminal telopeptide of type 1 collagen (CTx) [ 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Saranya Chumsri, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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