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).
Drug: Polyphenon E
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Locations near you
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Full eligibility criteria for NCT01060345
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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:
absolute neutrophil count >1,500/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.
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.
All locations for NCT01060345
United States (1)
The University of Chicago
Chicago, Illinois, United States, 60637
View full eligibility
Tris trial is registered with FDA with number: NCT01060345. The sponsor of the trial is University of Chicago and it is looking for 32 volunteers for the current phase.
Official trial title: A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
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