Probiotic for Breast Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must be taking: Aromatase inhibitors

Must not be taking: Antibiotics, Bisphosphonates, Denosumab, CDK 4/6 inhibitors

Disqualifiers: IBD, Chronic diarrhea, Celiac, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 52 weeks

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new probiotic treatment, WBF-038, to determine if it can prevent bone loss in individuals with early-stage hormone receptor-positive breast cancer who are starting aromatase inhibitors. Aromatase inhibitors lower estrogen levels to help stop certain breast cancers from growing, but they can also weaken bones. The trial aims to discover if WBF-038 can improve bone health and other factors like blood sugar and weight for these patients. Individuals starting aromatase inhibitors and diagnosed with this type of breast cancer might be suitable candidates for the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain treatments like bisphosphonates, denosumab, and CDK 4/6 inhibitors. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that WBF-038 is likely to be safe for humans?

Research has shown that WBF-038, a probiotic, is generally safe. The bacteria in the product are safe for use. WBF-038 contains no genetically modified organisms, which may enhance its safety. Studies have checked WBF-038 for side effects and found them manageable for breast cancer patients. Ongoing research aims to confirm these results, ensuring WBF-038 does not cause significant harm to participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for breast cancer, which often include chemotherapy, surgery, and radiation, WBF-038 is a probiotic. This makes it unique because it introduces a new approach by potentially leveraging the gut microbiome to support the body's natural defenses against cancer. Researchers are excited because this treatment could offer a gentler alternative with fewer side effects, aiming to improve patients' quality of life while complementing existing therapies.

What evidence suggests that WBF-038 is effective for preventing bone loss in early-stage hormone receptor-positive breast cancer?

Research has shown that the probiotic WBF-038, which participants in this trial will receive, might improve bone health, control blood sugar, and reduce weight and waist size in patients with early-stage hormone receptor-positive breast cancer. Aromatase inhibitors, a common treatment for this type of breast cancer, often cause bone loss. Studies suggest that WBF-038, a combination of prebiotics and probiotics, could help maintain bone strength and support metabolism. Although more research is needed, early results are promising for its potential to manage cancer treatment side effects. ^{2 3 6 7 8}

Who Is on the Research Team?

Saranya Chumsri, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for women over 18 with early-stage hormone receptor-positive breast cancer starting aromatase inhibitors. They must have certain blood and organ function levels, be willing to provide samples, and able to visit the study site. Exclusions include gut disorders, immune issues, recent antibiotics or surgery, osteoporosis treatments, known allergies to study product components or specific antibiotics.

Inclusion Criteria

I can care for myself and am up and about more than 50% of my waking hours.

Hemoglobin ≥ 9.0 g/dL (prior to registration)

Creatinine ≤ 2 x upper limit of normal (ULN) (prior to registration)

Exclusion Criteria

History of untreated vitamin D deficiency

I have a history of short gut syndrome or problems with how my intestines move food.

I've been on antibiotics recently and may need them for a while.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive WBF-038 orally once daily for 365 days

52 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• WBF-038

Trial Overview The trial tests a probiotic called WBF-038 in preventing bone loss for patients on aromatase inhibitors used in treating some breast cancers. It's a phase II trial assessing if this combination of prebiotics and probiotics can improve bone health as well as metabolic factors like blood sugar and weight.

How Is the Trial Designed?

Group I: Supportive care (WBF-038) Experimental Treatment 4 Interventions

Patients receive WBF-038 PO QD for 365 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and BMD test at screening and on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. mayo.edu mayo.edu/research/clinical-trials/cls-20583915

Clinical Trials The purpose of this is a prospective, pilot, single-arm study to evaluate the median percent change in C-terminal telopeptide of type 1 collagen (CTx) after WBF ...

2. withpower.com withpower.com/trial/phase-2-hormone-receptor-positive-breast-carcinoma-6-2025-257f6

Probiotic for Breast Cancer Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8053836/

Cost-effectiveness of ribociclib plus letrozole versus ... As demonstrated by the cost-effectiveness dominance over palbociclib, ribociclib results in savings when used as first-line treatment in postmenopausal women ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07044310/5-strain-probiotic-formulation-in-hr-positive-breast-cancer-receiving-aromatase-inhibitor-to-prevent-bone-loss?id=719&slug=ductal-carcinoma-in-situ-dcis

5-strain Probiotic Formulation in HR-positive Breast Cancer ... Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07044310?term=AREA%5BStudyType%5D(INTERVENTIONAL)&rank=5

5-strain Probiotic Formulation in HR-positive Breast Cancer ... Giving WBF-038 may improve bone turnover, bone health, blood sugar, weight, and waist circumference in patients with early-stage hormone receptor-positive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07044310

5-strain Probiotic Formulation in HR-positive Breast Cancer ... 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

7. mdpi.com mdpi.com/2072-6643/16/23/4219

Effects of Synbiotic Supplementation on Bone and ... Pendulum WBF-038 contains no genetically modified organisms, and its bacterial strains are generally recognized as safe. The IP will be provided to the research ...

8. breastcancertrials.org breastcancertrials.org/bct_nation/browse_trials.seam?zip=94107&nonTreatment=true&earlyStage=true&advancedStage=true&filterCategory=SCREENING&radiusMiles=-1

Browse Trials - BreastCancerTrials.org WBF-038 Prebiotic and Probiotic to Prevent Bone Loss for Women with Stage 0-III HR+ Breast Cancer Who Are Receiving an Aromatase Inhibitor. Phase 2 Trial of ...