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

Plain English Summary

Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery is a Phase 2 clinical trial sponsored by Mayo Clinic studying Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma. Tests how well Turkey Tail Mushrooms (TTM) work in post-menopausal women with HER2-negative, estrogen receptor-positive breast cancer before surgery. For women over 18 with newly diagnosed breast cancer, planning to have surgery. Participation involves taking TTM daily and completing questionnaires. Alternatives include standard chemotherapy and other treatments. The trial aims to enroll 40 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if over 18, post-menopausal, and have ER+ HER2- breast cancer. Not eligible if taking aromatase inhibitors, have active infections, or other serious health issues. Age: 18 years and older. Health: Must be post-menopausal and have certain blood test results within normal range. This trial is studying Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how much the tumor shrinks, which is important for patients as it could improve surgical outcomes. The specific primary outcome measures are: Change in Ki-67 (Baseline; at the time of surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial fills a gap by testing a natural supplement that may help shrink tumors before surgery. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma, where improved treatment options are needed.

Investor Insight

Market size is significant, with a large number of post-menopausal women with ER+ HER2- breast cancer. The competitive landscape is currently dominated by chemotherapy, making this trial potentially i Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if you are a good candidate for this trial. Participation involves taking a daily supplement and completing questionnaires. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 40 participants

Interventions

• DRUG: Coriolus Versicolor Extract — Dietary Supplement Given PO
• OTHER: Questionnaire Administration — Ancillary studies

Primary Outcomes

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

Secondary Outcomes

• 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)

Full 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

Trial Locations

• Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Frequently Asked Questions

Related Conditions

• Estrogen Receptor-Positive Breast Carcinoma
• HER2-Negative Breast Carcinoma
• Breast Cancer
• Oncology
• Cancer Treatment
• Natural Supplements
• Post-Menopausal Health
• Breast Surgery
• Cancer Research
• Alternative Medicine

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