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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00516243 |
RATIONALE: Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of green tea extract in treating women with hormone receptor-negative stage I, stage II, or stage III breast cancer.
Condition | Intervention | Phase |
Breast Cancer |
Drug: defined green tea catechin extract Drug: green tea extract Procedure: biopsy Procedure: gene expression analysis Procedure: histopathologic examination Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: mammography Procedure: mass spectrometry Procedure: protein expression analysis Procedure: quality-of-life assessment Procedure: questionnaire administration |
Phase I |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Mammography |
ChemIDplus related topics: | Epigallocatechin gallate Catechin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women With a History of Hormone Receptor-Negative Breast Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Patients undergo a core biopsy and mammogram of the contralateral breast at baseline and after 6 months for histological evaluation, IHC analysis, and mammographic density reading. Core biopsy tissue is assessed for proliferative changes and presence of atypia using standardized histological criteria. Core biopsy tissue is also analyzed by IHC for the following proteins: Ki-67 (proliferation index), p53, EGFR, HER2/neu, cleaved caspase-3 (apoptosis marker), and estrogen receptor (ER). Blood and urine samples are collected at baseline and every 2 months during treatment to measure drug effect biomarkers: serum estradiol, testosterone, insulin-like growth factor-1 (IGF-1), IGF binding protein-3 (IGFBP-3), and sex hormone-binding globulin (SHBG) by immunological laboratory methods; urine prostaglandin levels (PGE-M) by tandem mass spectrometry; urine oxidative damage markers (8-OHdG, isoprostane) and serum C-reactive protein (CRP) by ELISA; and catechol-O-methyltransferase (COMT) genotype (at baseline only).
Patients complete a questionnaire assessing quality of life (SF-36) and attitudes toward complementary and alternative medicine at baseline and at 6 months.
After completion of study treatment, patients are followed for 1 month.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
History of histologically confirmed stage I, II, or III breast carcinoma without evidence of disease at study entry
Hormone receptor status:
PATIENT CHARACTERISTICS:
Menopausal status:
No uncontrolled or significant co-morbid illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Willing to limit regular coffee consumption to ≤ three 8-ounce cups per day for 30 days prior to baseline evaluation and during the study intervention
No concurrent hormone replacement therapy, tamoxifen, or raloxifene
United States, New York | |||||
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting | ||||
New York, New York, United States, 10032 | |||||
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |||||
Memorial Sloan-Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Clifford A. Hudis, MD 646-888-4551 | |||||
United States, Texas | |||||
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |||||
M. D. Anderson Cancer Center at University of Texas | Recruiting | ||||
Houston, Texas, United States, 77030-4009 | |||||
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Scott M. Lippman, MD, FACP | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000557580, MDA-MDA04-4-01, MDA-2006-0521, CPMC-IRB-AAAB7638 |
First Received: | August 14, 2007 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00516243 |
Health Authority: | Unspecified |
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