A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Study Overview
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Brief Summary
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The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Detailed Description
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Many studies have shown that green tea may have anti-cancer and anti-inflammatory effects in cancer cells and animal models of breast cancer. Some studies have found that Asian women who drink many cups of green tea have lower rates of breast cancer. Green tea may have an effect on proliferative and inflammatory pathways. Women with ductal carcinoma in situ (DCIS) have been found to have inflammation in the breast tissue surrounding DCIS lesions. Inflammatory pathways are being studied for a possible link to cancer. This study is designed to evaluate changes in biomarkers of proliferation, inflammation, and angiogenesis in response to green tea intake.

Official Title
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A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)

Conditions
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Ductal Carcinoma in Situ

Intervention / Treatment
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* Drug: Polyphenon E


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume. Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis. Age >18 years. ECOG performance status <2 (Karnofsky >60%) Life expectancy of greater than 12 months. Normal organ and marrow function as defined below: leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL total bilirubin within normal institutional limits AST(SGOT) & ALT(SGPT)within normal institutional limits creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Pregnancy Patients who have undergone prior excisional biopsy for DCIS. Patients who are unable to undergo MRI due to claustrophobia or other reason. Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study. Patients receiving any other chemotherapy or investigational agents. History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea. Uncontrolled concurrent 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women with Ductal Carcinoma in Situ<br>Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E | Drug: Polyphenon E<br>* three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery<br>* Other names: Green tea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in K167 Staining |  | Prior to starting study and after 4-6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment. |  | Prior to study start and 4-6 weeks after treatment | 
| Change in Percent Staining of CD68 in Breast Tissue |  | Prior to study start and 4-6 weeks after treatment | 
| Change in Percent Staining of CD31 in Breast Tissue |  | Prior to study start and 4-6 weeks after treatment | 
| Change in Percent Staining of VEGF in Breast Tissue |  | Prior to study start and after 4-6 weeks of treatment | 
| Change in Serum Levels of IGF-1 |  | Prior to study start and after 4-6 weeks of treatment | 
| Safety of Green Tea Ingestion | Number of patients with adverse event. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCIS