Status:
COMPLETED
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Lead Sponsor:
Louisiana State University Health Sciences Center Shreveport
Collaborating Sponsors:
Columbia University
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00676793
Start Date
May 1 2004
End Date
July 1 2013
Last Update
September 21 2017
Active Locations (2)
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1
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
2
Columbia Presbyterian Hospital
New York, New York, United States, 10032