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.
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 completion of study treatment, patients are followed up 7-30 days after last dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Dietary Supplement Given PO
Ancillary studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
RECRUITINGChange in Ki-67
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.
Time frame: Baseline; at the time of surgery
Quality of life changes
Changes in quality of life will be assessed using the Symptom Experience Diary, which will be completed by study staff during weekly phone calls with participants. The Symptom Experience Diary consists of 2 yes/no questions and 10 questions answered on a scale of 0-10 where 0=none at all and 10=as bad as it can be.
Time frame: Up to 10 weeks
Adverse effects of Turkey Tail Mushrooms (TTM)
Adverse effects of TTM will be assessed by the number of patients with grade 2 or higher toxicities.
Time frame: Up to 10 weeks
Patient-reported outcomes
Patient reported outcomes will be assessed using the Symptom Experience Diary, which will be completed by study staff during weekly phone calls with participants. The Symptom Experience Diary consists of 2 yes/no questions and 10 questions answered on a scale of 0-10 where 0=none at all and 10=as bad as it can be.
Time frame: Up to 10 weeks
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