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Could a common mushroom help fight breast cancer? new trial investigates

NCT ID NCT06450873

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

    Contact Email: •••••@•••••

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