Phase 2
Completed N=32
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Source: ClinicalTrials.gov NCT00676793 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Change in Serum VEGF in Breast Cancer — 270 pg/ml — p==0.078
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum VEGF in Breast Cancer |
270 | =0.078 |
| PRIMARY Change in Serum HGF and Breast Cancer |
155.0 | =0.094 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00676793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.