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New treatment option for Anatomic Stage 0 Breast Cancer AJCC v8
Official title 5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss
ClinicalTrials.gov ID: NCT07044310
What this study is testing
What is WBF-038?
WBF-038 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for anatomic stage 0 breast cancer ajcc v8.
Also referred to as Akkermansia muciniphila/Anaerobutyricum hallii/Bifidobacterium infantis/Clostridium beijerinckii/Clostridium butyricum/Inulin WBF-038, Pendulum WBF-038 (SY).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Absolute neutrophil count (ANC) ≥ 1000/mm\^3 (prior to registration)
You likely can't join if
- 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...
- Immunocompromised patients including patients known to be HIV positive or those on chronic steroids \> 20 mg prednisone a day or...
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
See the full eligibility 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)
- 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...
- 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...
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.