Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Coriolus Versicolor Extract
DrugDietary Supplement Given PO
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment (TTM)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change 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 surgerySecondary outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
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Source ClinicalTrials.gov