Actively Recruiting
Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Led by Mayo Clinic · Updated on 2026-03-31
40
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Histologically confirmed ER-positive, HER2-negative breast cancer with Ki-67 of 10% or higher
- Scheduled for definitive breast surgery
- Detectable tumor larger than 5 mm by mammography or breast ultrasound
- Post-menopausal defined by last menstrual period over 12 months ago, bilateral oophorectomy, or specific hormone levels
- Not currently taking aromatase inhibitors or selective estrogen receptor modifiers
- ECOG performance status 0, 1, or 2 within 90 days before registration
- Platelet count of at least 100,000/mm3 within 90 days before registration
- Absolute neutrophil count of at least 1,000/mm3 within 90 days before registration
- Hemoglobin level of at least 11 g/dL within 90 days before registration
- Liver enzymes (ALT or AST) no more than 1.2 times the upper limit of normal within 90 days before registration
- Alkaline phosphatase no more than 1.2 times the upper limit of normal within 90 days before registration
- Serum creatinine no more than 1.2 times the upper limit of normal within 90 days before registration
- Able to provide written informed consent
- Able to complete the Symptom Experience Diary alone or with assistance
You will not qualify if you...
- Ki-67 less than 10%
- Current use of any medicinal mushrooms
- Locally advanced cancer requiring neoadjuvant therapy or metastatic cancer
- Currently receiving systemic chemotherapy
- Concurrent endocrine therapy with selective estrogen receptor modulators or aromatase inhibitors
- Allergy to mushrooms
- Severe co-morbid diseases or conditions that may interfere with study safety or assessments
- Immunocompromised status
- Known HIV positive patients currently on antiretroviral therapy
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents for cancer treatment
- Other active malignancies within 3 years except non-melanotic skin cancer or carcinoma-in-situ of the cervix
- Prior malignancy history if currently receiving chemotherapy treatment for that cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
C
Cancer Center Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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