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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06450873
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 25, 2024
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (TTM)
    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.

Primary Outcome Measure

Change in Ki-67 [ Time Frame: Baseline; at the time of surgery ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
  • Cancer Center Clinical Trials
    507-293-6386

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
855-776-0015
Cancer Center Clinical Trials
507-293-6386
Brenda J. Ernst, MD (PRINCIPAL_INVESTIGATOR)

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