5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prev… (NCT07044310) | Clinical Trial Compass
RecruitingPhase 2
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
United States38 participantsStarted 2025-07-25
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) ± 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)
Exclusion Criteria:
* Requires prolonged systemic antibiotic therapy for other conditions and recent systemic antibiotic ≤ 14 days prior to registration
* Fecal microbiota transplant (FMT) ≤ 6 months prior to registration
* FMT with an associated serious adverse event related to the FMT product or procedure
* Co-morbid systemic illnesses or other severe concurrent diseases which…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in C-terminal telopeptide of type 1 collagen (CTx)
Timeframe: 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