OncoMatch/Clinical Trials/NCT07044310
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
Is NCT07044310 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies WBF-038 for anatomic stage 0 breast cancer ajcc v8.
Treatment: WBF-038 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage 0, I, II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CDK4/6 inhibitor (abemaciclib, ribociclib, palbociclib)
Receiving or will receive CDK 4/6 inhibitor (abemaciclib, ribociclib, or palbociclib)
Cannot have received: chemotherapy
Received chemotherapy ≤ 30 days prior to registration
Cannot have received: oral bisphosphonate
Patients who received oral bisphosphonate within ≤ 12 weeks
Cannot have received: intravenous bisphosphonate (zoledronic acid)
intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks
Cannot have received: denosumab (denosumab)
denosumab ≤ 24 weeks
Cannot have received: bisphosphonate (alendronate, risedronate, ibandronate, pamidronate, zolendronic acid)
Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid)
Lab requirements
Blood counts
ANC ≥ 1000/mm^3; Platelet count ≥ 75,000/mm^3; Hemoglobin ≥ 9.0 g/dL; Albumin ≥ 3 g/dL
Kidney function
Creatinine ≤ 2 x ULN
Liver function
SGOT (AST) ≤ 2 x ULN
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 ULN (prior to registration); SGOT (AST) ≤ 2 x ULN (prior to registration); Albumin ≥ 3 g/dL (prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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