Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
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.
• 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) ± ovarian function suppression (OFS) per treating physician's discretion
• Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (prior to registration)
• Platelet count ≥ 75,000/mm\^3 (prior to registration)
• Hemoglobin ≥ 9.0 g/dL (prior to registration)
• Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) ≤ 2 x ULN (prior to registration)
• Albumin ≥ 3 g/dL (prior to registration)
• Willing and able to provide research stool and blood samples
• Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only (\< 60 years old with intact uterus)
• Capable of providing valid informed consent
• Willing to return to enrolling institution for all study visits (blood draws, etc)