Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT07044310
5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
A Phase 2 study testing Biospecimen Collection, Bone Mineral Density Test and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Bone Mineral Density Test and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 25 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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)
Who cannot join
- 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, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics
- Immunocompromised patients including patients known to be HIV positive or those on chronic steroids > 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
Show all 24Show fewer
- History of chronic diarrhea
- History of celiac disease
- Currently has a colostomy
- Intraabdominal surgery related to gastrointestinal tract ≤ 60 days prior to registration
- Evidence of active, severe colitis
- History of short gut syndrome or motility disorders
- Requires the daily use of medications to manage bowel hypermotility, such as imodium or lomotil
- Active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive products) prior to registration. Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment ≤ 30 days prior to registration are not excluded
- History of osteoporosis or hyperparathyroidism
- History of untreated vitamin D deficiency
- Receiving or will receive bisphosphonates during study period (alendronate, risedronate, ibandronate, pamidronate, or zolendronic acid) or denosumab
- Patients who received oral bisphosphonate within ≤ 12 weeks, intravenous (IV) zoledronic acid (Reclast) ≤ 52 weeks, or denosumab ≤ 24 weeks will also be excluded
- Known hypersensitivity to any component of study product (including known inulin intolerance)
- Known hypersensitivity to > 4 first-line antimicrobial therapies against akkermansia muciniphila, clostridium beijerinckii, clostridium butyricum, anaerobutyricum hallii, including penicillin, piperacillin, tetracycline, amoxicillin, or ampicillin
- Known hypersensitivity to > 4 first line antimicrobial therapies against bifidobacterium infantis Bi-26TM, including gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin
- Received an experimental product ≤ 30 days prior to registration
- Receiving or will receive CDK 4/6 inhibitor (abemaciclib, ribociclib, or palbociclib)
- Received chemotherapy ≤ 30 days prior to registration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Saranya Chumsri, MD
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the median percent change from baseline (prior to the start of an aromatase inhibitor [AI]) at 15 months in C-terminal telopeptide of type 1 collagen (CTx) in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline.
SECONDARY OBJECTIVES:
- To evaluate the median percent change from baseline (prior to the start of an AI) at 15 months in the lumbar spine and hip bone mineral density in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline.
II. To evaluate safety and risk of fracture associated with WBF-038.
EXPLORATORY OBJECTIVES:
- To evaluate changes from baseline (prior to the start of an AI) over time in CTx, alkaline phosphatase (ALK), fasting blood sugar (FBS), hemoglobin A1C (HbA1C), and Procollagen I Intact N-Terminal (P1NP) at 3, 6, 15, and 18 months post-baseline.
II. To evaluate changes from baseline (prior to the start of an AI) over time in weight and waist circumference at 3, 6, 15, and 18 months post-baseline.
III. To evaluate changes in the cytokine profile over time. IV. To evaluate the association between stool microbiome, stool short-chain fatty acid (SCFA), and serum SCFA and changes over time in CTx and lumbar spine and hip bone mineral density.
- To evaluate changes over time in AI-associated musculoskeletal symptoms (AIMSS) with patient-reported outcomes (PRO) using the Stanford Health Assessment Questionnaire (HAQ) and pain visual analog scale (VAS).
OUTLINE:
Patients receive WBF-038 orally (PO) once daily (QD) for 365 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and bone mineral density (BMD) test at screening and on study.
After completion of study intervention, patients are followed up at 90 days.
- Conditions
- 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
- Being tested
- Biospecimen Collection, Bone Mineral Density Test, Questionnaire Administration, WBF-038
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone Mineral Density TestProcedure or surgery
Also called BMD, bone density, Bone Density Test, bone mass
Undergo BMD
Questionnaire AdministrationOther
Ancillary studies
WBF-038Drug
Also called Akkermansia muciniphila/Anaerobutyricum hallii/Bifidobacterium infantis/Clostridium beijerinckii/Clostridium butyricum/Inulin WBF-038, Pendulum WBF-038 (SY), Probiotic/Prebiotic Formulation WBF-038 (SY), Synbiotic Formulation WBF-038 (SY)
Given WBF-038 PO
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (WBF-038) | Experimental | 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. Receives: Procedure: Biospecimen Collection; Procedure: Bone Mineral Density Test; Other: Questionnaire Administration; Drug: WBF-038 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-terminal telopeptide of type 1 collagen (CTx)
Assessed by standard lab tests at baseline (at study enrollment/eligibility assessment before any therapy) followed by 6 study visits. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Measured: 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
Secondary outcomes (3)
Change in lumbar spine mineral density
Will be measured by central dual energy x-ray absorptiometry. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Measured: Baseline; 365 days after start of WBF-038
Change in hip bone mineral density
Will be measured by central dual energy x-ray absorptiometry. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
Measured: Baseline; 365 days after start of WBF-038
Incidence of adverse events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Baseline; 90 days after start of AI therapy (before beginning WBF-038); 90 days after start of WBF-038; 365 days after starting WBF-038; 90 days after stopping WBF-038;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start25 Jul 2025
- Primary completion25 Jul 2027 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044310
- Sponsor's protocol ID
- MC240302
- Other IDs
- 24-007055
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
- ClinicalTrials.gov ID
- NCT07044310
- Acronym / sponsor ID
- MC240302
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 25 Jul 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the median percent change from baseline (prior to the start of an aromatase inhibitor [AI]) at 15 months in C-terminal telopeptide of type 1 collagen (CTx) in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline.
SECONDARY OBJECTIVES:
- To evaluate the median percent change from baseline (prior to the start of an AI) at 15 months in the lumbar spine and hip bone mineral density in early-stage breast cancer patients who receive WBF-038 treatment for 12 months starting at 3 months post-baseline.
II. To evaluate safety and risk of fracture associated with WBF-038.
EXPLORATORY OBJECTIVES:
- To evaluate changes from baseline (prior to the start of an AI) over time in CTx, alkaline phosphatase (ALK), fasting blood sugar (FBS), hemoglobin A1C (HbA1C), and Procollagen I Intact N-Terminal (P1NP) at 3, 6, 15, and 18 months post-baseline.
II. To evaluate changes from baseline (prior to the start of an AI) over time in weight and waist circumference at 3, 6, 15, and 18 months post-baseline.
III. To evaluate changes in the cytokine profile over time. IV. To evaluate the association between stool microbiome, stool short-chain fatty acid (SCFA), and serum SCFA and changes over time in CTx and lumbar spine and hip bone mineral density.
- To evaluate changes over time in AI-associated musculoskeletal symptoms (AIMSS) with patient-reported outcomes (PRO) using the Stanford Health Assessment Questionnaire (HAQ) and pain visual analog scale (VAS).
OUTLINE:
Patients receive WBF-038 orally (PO) once daily (QD) for 365 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and bone mineral density (BMD) test at screening and on study.
After completion of study intervention, patients are followed up at 90 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (WBF-038) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Mineral Density Test, Other: Questionnaire Administration, Drug: WBF-038Patients 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (24 listed)
- 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, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of over-the-counter probiotics
- Immunocompromised patients including patients known to be HIV positive or those on chronic steroids > 20 mg prednisone a day or prednisone-equivalent. Note: Must be off systemic steroids ≥ 90 days prior to registration. However, topical steroids, inhalants, or steroid eye drops are permitted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Supportive care (WBF-038) |
| Bone Mineral Density TestAlso: BMD, bone density, Bone Density Test, bone massUndergo BMD | Procedure or surgery | Supportive care (WBF-038) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (WBF-038) |
| WBF-038Also: Akkermansia muciniphila/Anaerobutyricum hallii/Bifidobacterium infantis/Clostridium beijerinckii/Clostridium butyricum/Inulin WBF-038, Pendulum WBF-038 (SY), Probiotic/Prebiotic Formulation WBF-038 (SY), Synbiotic Formulation WBF-038 (SY)Given WBF-038 PO | Drug | Supportive care (WBF-038) |
Primary outcome
Change in C-terminal telopeptide of type 1 collagen (CTx)
Time frame: 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
Assessed by standard lab tests at baseline (at study enrollment/eligibility assessment before any therapy) followed by 6 study visits. Participants receive aromatase Inhibitor (AI) therapy followed by a one-year course of probiotic WBF-038.
3 secondary outcomes
Change in lumbar spine mineral density
Time frame: Baseline; 365 days after start of WBF-038
Change in hip bone mineral density
Time frame: Baseline; 365 days after start of WBF-038
Incidence of adverse events
Time frame: Baseline; 90 days after start of AI therapy (before beginning WBF-038); 90 days after start of WBF-038; 365 days after starting WBF-038; 90 days after stopping WBF-038;
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saranya Chumsri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Bone Mineral Density Test and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-terminal telopeptide of type 1 collagen (CTx) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.