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

NCT06450873 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MC22030523-003846
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Ki-67

  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.

  Baseline; at the time of surgery

Secondary Outcomes (3)

• Quality of life changes

  Up to 10 weeks

• Adverse effects of Turkey Tail Mushrooms (TTM)

  Up to 10 weeks

• Patient-reported outcomes

  Up to 10 weeks

Study Arms (1)

Treatment (TTM)

EXPERIMENTAL

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.

Drug: Coriolus Versicolor Extract; Other: Questionnaire Administration

Interventions

Coriolus Versicolor Extract DRUG

Dietary Supplement Given PO

Also known as: Turkey Tail Mushroom Extract, Yunzhi Extract

Treatment (TTM)

Questionnaire Administration OTHER

Ancillary studies

Treatment (TTM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

VPS Coriolus versicolor extract

Study Officials

• Brenda J. Ernst, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

CONTACT

507-293-6386

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)