Is NCT07044310 recruiting in Jacksonville, FL?

Yes, NCT07044310 is currently recruiting participants at its Jacksonville, FL location. This anatomic stage 0 breast cancer ajcc v8 clinical trial is actively enrolling qualified participants.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anatomic Stage 0 Breast Cancer AJCC v8 Clinical Trial in Jacksonville, FL

Q: How do I join the anatomic stage 0 breast cancer ajcc v8 clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anatomic Stage 0 Breast Cancer AJCC v8 Study in Jacksonville

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.

Sponsor: Mayo Clinic

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT07044310) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anatomic Stage 0 Breast Cancer AJCC v8 Treatment Options in Jacksonville, FL

If you're searching for anatomic stage 0 breast cancer ajcc v8 treatment options in Jacksonville, FL, this clinical trial (NCT07044310) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anatomic stage 0 breast cancer ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anatomic stage 0 breast cancer ajcc v8 clinical trials near you to find additional studies recruiting in your area.

Anatomic Stage 0 Breast Cancer AJCC v8 Clinical Trial in Jacksonville, FL

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