Using turkey tail mushroom to treat post-menopausal women with specific breast cancer before surgery

A Phase 2 Pilot Window of Opportunity Study Turkey Tail Mushrooms (TTM) (Trametes Versicolor) in Post-Menopausal Women With HER2 (-) ER (+) Breast Cancer Planning to Undergo Surgical Therapy

This study is testing if taking turkey tail mushroom can help post-menopausal women with a specific type of breast cancer feel better and improve their tumors before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Mayo Clinic (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Scottsdale, Arizona)
• Trial ID: NCT06450873 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of turkey tail mushroom (TTM) in treating post-menopausal women diagnosed with HER2-negative, estrogen receptor-positive breast cancer who are scheduled for surgery. Participants will take TTM orally twice daily for up to 42 days prior to their surgery, with the primary goal of assessing changes in tumor proliferation. Secondary objectives include evaluating any adverse effects of TTM and measuring changes in quality of life, mood, and energy levels during treatment. The study aims to gather evidence on the potential benefits of TTM in this patient population.

Who should consider this trial

Good fit: Ideal candidates are post-menopausal women aged 18 and older with newly diagnosed HER2-negative, ER-positive breast cancer who are scheduled for definitive surgery.

Not a fit: Patients with non-measurable disease or those currently taking aromatase inhibitors or selective estrogen receptor modifiers may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance tumor response and improve quality of life for patients undergoing surgery for breast cancer.

How similar studies have performed: Previous studies have shown promising results with TTM in cancer treatment, suggesting potential efficacy in this novel application.

Eligibility criteria

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

Where this trial is running

Scottsdale, Arizona

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)

Study contacts

• Principal investigator: Brenda J. Ernst, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office

Conditions: Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma