RECRUITING

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

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Conditions

Estrogen Receptor-Positive Breast CarcinomaHER2-Negative Breast Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-25
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06450873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women ≥ 18 years of age
  2. * 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.
  3. * Scheduled for definitive breast surgery
  4. * Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size.
  5. * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible
  6. * Post menopausal as defined by:
  7. * Self-reported last menstrual period greater than 12 months, or
  8. * Bilateral oophorectomy, or
  9. * Follicle stimulating hormone (FSH) \>20 mIU/mL, and estradiol level ≤ 20 pg/mL
  10. * Not taking aromatase inhibitor or a selective estrogen receptor modifier
  11. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  12. * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 90 days prior to registration)
  13. * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (obtained ≤ 90 days prior to registration)
  14. * Hemoglobin ≥ 11 g/dL (obtained ≤ 90 days prior to registration)
  15. * Serum transaminase \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\] ≤ 1.2 x upper limit of normal (ULN) (obtained ≤ 90 days prior to registration)
  16. * Alkaline phosphatase ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
  17. * Serum creatinine ≤ 1.2 x ULN (obtained ≤ 90 days prior to registration)
  18. * Provide written informed consent
  19. * Ability to complete the Symptom Experience Diary by themselves or with assistance
  1. * Current use of any medicinal mushrooms
  2. * Patient with locally advanced cancer who will require neoadjuvant therapy or metastatic cancer
  3. * Currently on chemotherapy
  4. * Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors)
  5. * Allergy to mushrooms
  6. * 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
  7. * Immunocompromised patients
  8. * Patients known to be HIV positive and currently receiving antiretroviral therapy.
  9. * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  10. * Uncontrolled intercurrent illness including, but not limited to:
  11. * Ongoing or active infection
  12. * Symptomatic congestive heart failure
  13. * Unstable angina pectoris
  14. * Cardiac arrhythmia
  15. * Or psychiatric illness/social situations that would limit compliance with study requirements
  16. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  17. * Other active malignancy 3 years prior to registration
  18. * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  19. * NOTE: If there is a history of prior malignancy, they must not be receiving chemotherapy treatment for their cancer

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Larry R. Bergstrom, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Larry R. Bergstrom, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-25
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-10-25
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Estrogen Receptor-Positive Breast Carcinoma
  • HER2-Negative Breast Carcinoma