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

Recruiting Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
38 (estimated)
Sponsor
Mayo Clinic · Other
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About This Trial
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 a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Female age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Histologically confirmed anatomical stage 0-III hormone receptor-positive breast cancer * Will be starting on an aromatase inhibitor (letrozole, anastrozole, or exemestane) ± ovar…
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