Could a common mushroom help fight breast cancer? new trial investigates
NCT ID NCT06450873
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether turkey tail mushroom extract can slow or shrink estrogen receptor-positive, HER2-negative breast cancer in post-menopausal women. Forty participants will take the supplement between diagnosis and surgery, and researchers will measure changes in a tumor growth marker called Ki-67. The study builds on earlier evidence suggesting these mushrooms may have anti-cancer effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Turkey tail mushroom extract (Coriolus versicolor)
- What this could lead to
- If it works, this could point toward a natural supplement that helps shrink tumors or improve outcomes in certain breast cancers before surgery.
- What could go wrong
- This is a small, early-phase pilot study with only 40 participants. It measures a biomarker (Ki-67), not survival or cure, so results may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Apr 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women ≥ 18 years of age * Histological confirmation of ER+, HER2- breast cancer, newly diagnosed and tissue available for central confirmation of Ki-67 measurement. Subjects are eligible if they have a Ki-67 of ≥10%. Ki-67 will be repeated for patients who have had this done externally. * Scheduled for definitive breast surgery * Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size. * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible * Post menopausal as defined by: * Self-reported last menstrual period greater than 12 months, or * Bilateral oophorectomy, or * Follicle stimulating hormone (FSH) \>20 mIU/mL, and estradiol level ≤ 20 pg/mL * Not taking aromatase inhibitor or a selective estrogen receptor modifier * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 obtained ≤ 90 days prior to registration * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 90 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (obtained ≤ 90 days prior to registration) * Hemoglobin ≥ 11 g/dL (obtained ≤ 90 days prior to registration) * Serum transaminase \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\] ≤ 1.2 x upper limit of normal (ULN) (obtained ≤ 90 days prior to registration) * Alkaline phosphatase ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration) * Serum creatinine ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration) * Provide written informed consent * Ability to complete the Symptom Experience Diary by themselves or with assistance Exclusion Criteria: * Ki-67 of \<10% * Current use of any medicinal mushrooms * Patient with locally advanced cancer who will require neoadjuvant therapy or metastatic cancer * Currently on systemic chemotherapy * Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors) * Allergy to mushrooms * Co-morbid systemic illnesses or other severe concurrent disease 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 the prescribed regimens * Immunocompromised patients * Patients known to be HIV positive and currently receiving antiretroviral therapy. * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Or psychiatric illness/social situations that would limit compliance with study requirements * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy 3 years prior to registration * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * NOTE: If there is a history of prior malignancy, they must not be receiving chemotherapy treatment for their cancer
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Estrogen receptor-positive breast carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Mayo Clinic in Arizona
RECRUITINGScottsdale, Arizona, 85259, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Fasting during chemo: a new way to boost treatment?
- Can a smart drug cross the Blood-Brain barrier to attack breast cancer metastases?
- Engineered immune cells join chemo and antibody to attack Hard-to-Treat breast cancer
- Could a common cholesterol drug boost breast cancer treatment?
- CBD oil tested for breast cancer drug side effect
- Can a smartphone app help breast cancer patients stay on track with Life-Saving pills?