RecruitingPhase 2

5-strain Probiotic Formulation in HR-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

Phase 2 Trial of 5-Strain Probiotic Formulation in Hormone Receptor-Positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 365 days
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether WBF-038, a mix of helpful bacteria and nutrients that feed them, can help prevent bone loss. It is for women with early-stage breast cancer that uses hormones to grow who are starting an aromatase inhibitor, a drug that lowers estrogen.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Have stage 0–III hormone receptor-positive breast cancer, confirmed by a tissue test.
  • Can care for yourself and are up and about at least half of your waking hours.
  • Plan to start letrozole, anastrozole, or exemestane, with or without treatment to stop the ovaries from working.
  • Blood tests meet study limits for blood cell counts, kidney and liver health, and albumin, a blood protein.
  • Willing to give stool and blood samples and return to the study center for all visits.
  • Have a negative blood pregnancy test within 7 days before signing up, if under 60 and still have a uterus.
  • Can understand the study and give consent to take part.

Who can't join

  • Need long-term antibiotics that work throughout the body, or used them within 14 days; had a stool transplant within 6 months, or ever had a serious problem from one.
  • Have a serious illness that could make the study unsafe, a weakened immune system, HIV, or certain steroid use. Steroids that work throughout the body must be stopped at least 90 days before signing up; skin, inhaled, and eye steroids are allowed.
  • Have inflammatory bowel disease, long-term diarrhea, celiac disease, severe active colon swelling, short bowel syndrome, bowel movement disorders, or a colostomy; need daily medicine to slow the bowels; or had digestive tract surgery within 60 days.
  • Have an autoimmune disease, where the immune system attacks the body, needing whole-body treatment within 30 days. Hormone replacement does not count.
  • Have osteoporosis, meaning weak bones; overactive parathyroid glands; or untreated low vitamin D.
  • Use or plan to use bisphosphonates or denosumab, medicines that protect bones. Recent use also rules you out: oral bisphosphonates within 12 weeks, IV zoledronic acid within 52 weeks, or denosumab within 24 weeks.
  • Are allergic to a study ingredient, cannot tolerate inulin, or have allergies to more than four of the listed first-choice antibiotics for the study bacteria.
  • Used an experimental product or had chemotherapy within 30 days, or use or plan to use abemaciclib, ribociclib, or palbociclib.

Simplified for readability. The official criteria below are what the study team uses.

Official 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) ± 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, 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 * 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

Study sites (1)

FL