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

What this trial studies

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.

Conditions in scope

• Estrogen Receptor-Positive Breast Carcinoma
• HER2-Negative Breast Carcinoma

Interventions

• Coriolus Versicolor Extract (Drug) — Dietary Supplement Given PO
• Questionnaire Administration (Other) — Ancillary studies

Who can join

Women only · Ages 18 Years and up

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

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2024-10-25
• Primary completion: 2027-12-30
• Last update posted: 2026-03-31
• First posted: 2024-06-10

Sponsor & contact

Lead sponsor: Mayo Clinic (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.