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
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To determine changes in proliferation (Ki-67) in ER+HER2- breast cancers that receive turkey tail administration. SECONDARY OBJECTIVES: I. To assess associated adverse effects of coriolus versicolor extract (TTM). II. To determine if quality of life (QOL), mood and energy levels change while taking TTM. OUTLINE: Patients receive TTM orally (PO) twice daily (BID) starting at the time of study registration and continuing up to the day prior to standard of care (SOC) surgery (up to 20-42 days) in the absence of disease progression or unacceptable toxicity. After comple…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DrugCoriolus Versicolor Extract
Dietary Supplement Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- Mayo Clinic in ArizonaScottsdale, Arizona