A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.

Key facts

Study ID

NCT00676793

Run by

Louisiana State University Health Sciences Center Shreveport

People needed

32

Starts

2004-05-01

Expected to finish

2013-07-01

Last updated by the study team

2017-09-21

Who can join

Age: 21 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Definitive biopsy demonstrating primary breast cancer
• Residual breast cancer requiring additional surgical resection
• Stage I, II or III disease
• Patient has ability to give signed informed consent
• Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).
• ECOG Performance status of 0 or 1.
• Age ≥ 21 years and less than 75

You may not qualify if…

• Prior hormonal or surgical therapy for breast cancer
• Abnormal liver function test
• Liver or kidney problems that would interfere with metabolism of study drug
• Any condition that would hamper informed consent or ability to comply with study protocol
• Participation in another research study in the last three months
• Known malignancy at any site other than breast
• Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
• Allergy or intolerance to any component of green tea
• Inability or refusal to comply with definitive surgical therapy

Where it is running

• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Columbia Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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