Estrogen Receptor-Positive Breast Carcinoma study: Coriolus Versicolor Extract
Official title Turkey Tail Mushroom for Treating Post-Menopausal Women With HER2-Negative ER-Positive Breast Cancer Undergoing Surgery
ClinicalTrials.gov ID: NCT06450873
What this study is testing
What is Coriolus Versicolor Extract?
This is an investigational dietary supplement being studied as a potential treatment for estrogen receptor-positive breast cancer.
Also referred to as Turkey Tail Mushroom Extract, Yunzhi Extract.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if taking turkey tail mushroom is effective for women with HER2-negative, estrogen receptor-positive breast cancer who are scheduled for surgery.
- Who it's for
- The study is looking for post-menopausal women with HER2-negative, estrogen receptor-positive breast cancer who are planning to have surgery.
- What's involved
- Participants will take turkey tail mushroom, a type of mushroom used in traditional medicine, while waiting for their surgery.
- Time commitment
- The study focuses on the two-month period between diagnosis and surgery, though specific visit schedules are not detailed in the source.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women ≥ 18 years of age
- Histological confirmation of ER+, HER2- breast cancer, newly diagnosed and tissue available for central confirmation of Ki-67 measurement.
- 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
You likely can't join if
- 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
- Concurrent endocrine therapy (selective estrogen receptor modifiers or aromatase inhibitors)
- Allergy to mushrooms
See the full eligibility 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. people are eligible if they have a Ki-67 of ≥10%.
- 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
- 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
- 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
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.