Breast Cancer
Conditions
Keywords
breast cancer, EGCG, Polyphenon E, c-Met, VEGF, HGF
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 changes in serum and tissue biomarkers related to progression of cancer. The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective. 1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer 1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF 1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population
Interventions
DRUGPolyphenon E
Four 200mg capsules daily taken with a meal, for the duration of the study.
Sponsors
Columbia University
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum VEGF in Breast Cancer | Baseline and 4 to 6 weeks | Change in serum VEGF from baseline to post treatment with polyphenon E. |
| Change in Serum HGF and Breast Cancer | Baseline and 4 to 6 weeks | Change in serum HGF from baseline to post Polyphenol E treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ECGC and Breast Cancer Single arm for a phase II study of EGCG extract and breast cancer. Subjects are asked to take 4 polyphenol E (200mg) capsules daily with a meal for the duration of the study. Biomarkers are measured at baseline and then again at presurgery, the end point for the study. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | ECGC and Breast Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Change in Serum HGF and Breast Cancer
Change in serum HGF from baseline to post Polyphenol E treatment.
Time frame: Baseline and 4 to 6 weeks
Population: Number of participants for analysis was determined per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECGC and Breast Cancer | Change in Serum HGF and Breast Cancer | 155.0 pg/ml |
Comparison: The null hypothesis is that there is no change, i.e. median change=0.0.p-value: =0.094Wilcoxon (Mann-Whitney)
Primary
Change in Serum VEGF in Breast Cancer
Change in serum VEGF from baseline to post treatment with polyphenon E.
Time frame: Baseline and 4 to 6 weeks
Population: Number of participants for analysis was determined per protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECGC and Breast Cancer | Change in Serum VEGF in Breast Cancer | 270 pg/ml |
Comparison: The null hypothesis is that there is no change, i.e. median change=0.0.p-value: =0.078Wilcoxon (Mann-Whitney)