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Turkey Tail Mushroom for HER2-Negative ER-Positive Breast Cancer

This study is testing if turkey tail mushroom (Coriolus Versicolor Extract) can help post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer before surgery. Researchers want to see if taking turkey tail mushroom can change how quickly cancer cells grow (measured by something called Ki-67). You could be eligible if you are a woman aged 18 or older with this type of breast cancer, and your cancer has a Ki-67 level of 10% or higher. The study plans to enroll 40 participants. The current status of this study is unclear.

Study design
This study is testing turkey tail mushroom in 40 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
You would take turkey tail mushroom orally twice daily from when you join the study until the day before your surgery, which could be up to 20-42 days.
Compensation
Not stated in the trial record.
Follow-up
After you finish taking the study treatment, you will be followed up 7-30 days after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06450873

Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~40 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:Coriolus Versicolor ExtractQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Ki-67
Measured over Baseline; at the time of surgery

Conditions

Estrogen Receptor-Positive Breast Carcinoma
HER2-Negative Breast Carcinoma

Explore related trials

Breast CarcinomaMKI67 Gene

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Brenda J. Ernst, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Ki-67Baseline; at the time of surgery

    Change in Ki-67 from the time of enrollment (pre-treatment) to the time of surgery (post-treatment) will be recorded. Slides from the original biopsy at the time of diagnosis will be used to assess pre-treatment Ki-67. A tissue sample obtained at the time of surgery will be used to assess Ki-67 post-treatment.