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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00516243 |
Purpose
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 |
Dietary Supplement: Polyphenon E Other: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Polyphenon E
Starting dose 2 x 200 mg (400 mg) capsules of Poly E, 2 times per day for 6 months.
|
Dietary Supplement: Polyphenon E
Starting dose green tea catechin extract "Poly E" 400 mg twice a day (BID) of EGCG (2x200 mg caps BID), second escalated dose 600 mg BID of EGCG (3x200 mg caps BID), and third escalated dose 800 mg BID of EGCG (4x200 mg).
Other Names:
|
| Placebo Comparator: Placebo |
Other: Placebo
Starting placebo dose will be matching study Poly E (2, 3 or 4 capsules BID).
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Texas | |
| Dan L. Duncan Cancer Center at Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Principal Investigator: | Therese B. Bevers, MD, BS | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00516243 History of Changes |
| Other Study ID Numbers: | 2006-0521, MDA-MDA04-4-01, MDA-2006-0521, CPMC-IRB-AAAB7638, CDR0000557580 |
| Study First Received: | August 14, 2007 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |