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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Ki-67
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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 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
研究组 & 干预措施
Treatment (TTM)
Patients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 3-6 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: Coriolus Versicolor Extract (Drug)
Treatment (TTM)
Patients receive TTM PO BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 3-6 weeks) in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in Ki-67
时间窗: Baseline; at the time of surgery
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.
次要结局
- Patient-reported outcomes(Up to 10 weeks)
- Quality of life changes(Up to 10 weeks)
- Adverse effects of Turkey Tail Mushrooms (TTM)(Up to 10 weeks)