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Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer



Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer

For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Polyphenon E (green tea extract) and low-doseaspirin may be effective in preventing the development of breast cancer. PURPOSE: Randomizedphase II trial to compare the effectiveness of Polyphenon E with that of low-dose aspirin in preventing breast cancer in women who are at high risk of developing breast cancer.
Details: OBJECTIVES: Primary - Determine the effect of Polyphenon E (green tea extract), low-dose aspirin, or placebo on breast cytology and nipple fluid basic fibroblast growth factor (bFGF) in women at high risk for developing breast cancer. Secondary - Determine the toxic effects of these drugs in these participants. - Correlate the modulation of multiple other investigational molecular markers with these drugs in these participants. OUTLINE: This is a randomized, placebo-controlled study. Participants are stratified according to breast cytology (benign vs atypical). Participants are randomized to 1 of 3 arms. - Arm I: Participants receive oral Polyphenon E (green tea extract) once daily. - Arm II: Participants receive oral low-dose aspirin once daily. - Arm III: Participants receive oral placebo once daily. In all arms, treatment continues for 6 months in the absence of unacceptable toxicity. Participants undergo breast examination, nipple fluid aspiration, and ductal lavage and/or breast fine needle aspiration at baseline and 6 months. Participants are followed every 6 months for up to 10 years. PROJECTED ACCRUAL: A total of 288 participants (96 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type:
  Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Predicted 5-year risk for breast cancer of at least 1.66% - Prior history of breast cancer allowed - Normal breast exam and breast-related radiological tests - No malignant breast cytology - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Complete blood count normal - Platelet count normal - No bleeding disorder Hepatic - Liver function normal - Coagulation profile normal Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile participants must use effective contraception - Electrolytes normal - No allergy to tea or aspirin - No non-breast malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or benign tumors (e.g., adenomas) - No medical condition that would contraindicate aspirin use (e.g., asthma or peptic ulcer disease) - No significant medical or psychiatric condition that would preclude study eligibility PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No prior breast augmentation or reduction surgery - More than 3 months since prior invasive breast procedure Other - More than 6 months since prior experimental drugs - More than 6 months since prior cancer-related treatment - No concurrent drug that would complicate aspirin administration - No other concurrent experimental drugs - No concurrent cancer-related treatment
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MaiBrooks,  Principal Investigator,  Jonsson Comprehensive Cancer Center

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1782
United States
Recruiting Mai  Brooks 310-206-2215


Additional Information:
Study ID Numbers:
  CDR0000341682;  UCLA-0305011
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074061

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