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Trial Title:
Turkey Tail Mushroom for Treating Post-Menopausal Women with HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
NCT ID:
NCT06450873
Condition:
Estrogen Receptor-Positive Breast Carcinoma
HER2-Negative Breast Carcinoma
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Coriolus Versicolor Extract
Description:
Dietary Supplement Given PO
Arm group label:
Treatment (TTM)
Other name:
Turkey Tail Mushroom Extract
Other name:
Yunzhi Extract
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (TTM)
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.
Detailed 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) once daily (QD) or 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 3-6 weeks) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up 7-30 days after last dose.
Criteria for eligibility:
Criteria:
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. 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
- Follicle stimulating hormone (FSH) >20 mIU/mL, and estradiol level ≤ 20 pg/mL
- Not taking aromatase inhibitor or a selective estrogen receptor modifier
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Platelet count ≥ 100,000/mm^3 (obtained ≤ 90 days prior to registration)
- Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (obtained ≤ 90 days prior to
registration)
- Hemoglobin ≥ 11 g/dL (obtained ≤ 90 days prior to registration)
- Serum transaminase [alanine aminotransferase (ALT) or aspartate aminotransferase
(AST)] ≤ 1.2 x upper limit of normal (ULN) (obtained ≤ 90 days prior to
registration)
- Alkaline phosphatase ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
- Serum creatinine ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
- Provide written informed consent
- Ability to complete the Symptom Experience Diary by themselves or with assistance
Exclusion Criteria:
- Current use of any medicinal mushrooms
- Patient with locally advanced cancer who will require neoadjuvant therapy or
metastatic cancer
- Currently on 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
- Patients known to be HIV positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an
immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study
requirements
- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm
- Other active malignancy 3 years prior to registration
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
- NOTE: If there is a history of prior malignancy, they must not be receiving
chemotherapy treatment for their cancer
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Larry R. Bergstrom, MD
Start date:
October 25, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06450873
https://www.mayo.edu/research/clinical-trials
