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.
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…
Contacts