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What is this study?
5-strain Probiotic Formulation in Hormone Receptor-positive Breast Cancer Receiving Aromatase Inhibitor to Prevent Bone Loss is a research study for people with early‑stage, hormone receptor‑positive breast cancer who are starting treatment with an aromatase inhibitor (a common hormone therapy).
The goal of the study is to learn how an investigational probiotic product called WBF‑038 may affect bone health during breast cancer treatment. Some breast cancer treatments can lead to bone loss over time, and this study is looking at whether WBF‑038 may help reduce changes linked to bone breakdown. Researchers will measure a blood marker related to bone health at the start of the study and again after 3 months and 12 months of treatment.
Who is this study for?
You may be eligible to participate if you:
- Are a woman age 18 or older
- Have stage 0–III hormone receptor‑positive breast cancer
- Are about to start an aromatase inhibitor (such as letrozole, anastrozole, or exemestane)
- Are able to attend study visits and provide blood and stool samples
- Are generally healthy enough to take part, based on lab tests and medical history
The study team reviews eligibility carefully to help ensure participation is safe and appropriate for each person.
Who cannot take part?
You would not be able to join this study if you have certain conditions that affect the digestive system or immune system, such as:
- Inflammatory bowel disease, chronic diarrhea, or celiac disease
- Recent major gastrointestinal surgery
- Certain autoimmune conditions requiring recent treatment
- Osteoporosis, parathyroid disease, or untreated vitamin D deficiency
- Recent use of specific bone‑strengthening medications or chemotherapy
- Known allergies to ingredients in the study product or related antibiotics
These restrictions are in place to help protect participant safety and ensure accurate study results.
Are there benefits?
You may not receive a direct medical benefit from taking part. However, your participation may help researchers:
- Better understand bone health during breast cancer treatment
- Improve supportive care for future patients
- Advance knowledge about how probiotics may interact with cancer treatment
Are there risks?
All research studies involve some risks or inconveniences. These may include:
- Time and travel for study visits
- Blood draws
- Possible side effects related to the study product
The study team will review known risks with you in detail and answer any questions you have.
Do I have to participate?
No. Participation is completely voluntary.
- You can choose not to take part
- You can leave the study at any time
How do I learn more?
If you are interested or have questions, you can contact the Clinical Trials Referral Office at 855-776-0015 or mayocliniccancerstudies@mayo.edu.
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I am ready to start my Anastrozole after I finish radiation, but unfortunately, I do qualify for the study as I also have leukemia, Vitamin B and D therapy, Immunity disorder, and sjogren's. I would like to learn about the progress of the study, however, if I am allowed.
Hi @gailmarienewton, thanks for your interest in the study. We have a section of our blog that's dedicated to research discoveries and when we have an update on this one, we'll be sure to publish it in our newsfeed.