Recruiting
Phase 2

Turkey Tail Mushroom

Sponsor:

Mayo Clinic

Code:

NCT06450873

Conditions

Estrogen Receptor-Positive Breast Carcinoma

HER2-Negative Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coriolus Versicolor Extract

Questionnaire Administration

Study Details

Brief summary:

This phase II trial tests how well turkey tail mushroom (TTM) works in treating post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer undergoing surgery. TTM is a common mushroom. In traditional Chinese medicine, it is used for enhancing function and removing toxins, as well as for cancer, hepatitis, and infections. There is previous evidence of significant tumor shrinkage occurring in the 2-month window between diagnosis and surgery in women who have taken TTM. Giving TTM may be effective in treating post-menopausal women with HER2-negative, ER-positive breast cancer undergoing surgery.

Conditions

Estrogen Receptor-Positive Breast Carcinoma

HER2-Negative Breast Carcinoma

Study ID

NCT06450873

Start date

Oct 25, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (TTM)

Patients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 20-42 days) in the absence of disease progression or unacceptable toxicity.

Interventions

Coriolus Versicolor Extract

Dietary Supplement Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in Ki-67 [ Time Frame: Baseline; at the time of surgery ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

507-293-6386

Principal Investigator:

Brenda J. Ernst, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-31.