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

Launched by MAYO CLINIC · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of turkey tail mushroom, a common mushroom known for its potential health benefits, in treating post-menopausal women who have been newly diagnosed with a specific type of breast cancer called HER2-negative, estrogen receptor-positive breast cancer. The goal is to see if taking turkey tail mushroom can help shrink tumors before surgery. Researchers believe that the mushroom may enhance the body's ability to fight cancer, based on previous findings that showed significant tumor reduction in women who took it prior to surgery.

To participate, women need to be at least 18 years old, have a confirmed diagnosis of the specified breast cancer, and be scheduled for surgery. They must also meet several health criteria, such as having a certain level of blood cell counts and not currently using other cancer treatments. Participants can expect to take turkey tail mushroom during the lead-up to their surgery and will be monitored closely throughout the study. It's important to note that those with certain health issues or who are currently undergoing other treatments may not be eligible to join.

Gender

FEMALE

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 obtained ≤ 90 days prior to registration
• • 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 systemic 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