Clinical trial · Interventional
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Phase II Clinical Trial to Determine if Polyphenon E Inhibits c-Met Signaling and Activation of Pathways Contributing to Breast Cancer Progression
NCT00676793CI-TRIAL-00029630completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polyphenon E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Polyphenon E
- description
- This is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer.
- interventionNames
- Drug: Polyphenon E
Primary outcomes (2)
- measure
- Change in Serum VEGF in Breast Cancer
- timeFrame
- Baseline and 4 to 6 weeks
- description
- Change in serum VEGF from baseline to post treatment with polyphenon E.
- measure
- Change in Serum HGF and Breast Cancer
- timeFrame
- Baseline and 4 to 6 weeks
- description
- Change in serum HGF from baseline to post Polyphenol E treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTProffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05