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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Louisiana State University Health Sciences Center Shreveport
• Collaborator: Columbia University

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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