RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Green tea extract (Polyphenon® E) and low-dose aspirin may be effective in preventing the development of breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of green tea extract with that of low-dose aspirin in preventing breast cancer in women who are at high risk of developing breast cancer.

Condition	Treatment or Intervention	Phase
Breast Cancer	Drug: aspirin  Drug: green tea extract  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the effect of green tea extract (Polyphenon® E), 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 green tea extract (Polyphenon® E) 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1782,  United States

Study chairs or principal investigators

Mai N. Brooks, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000341682; UCLA-0305011; NCT00074061
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  December 10, 2003
ClinicalTrials.gov Identifier:  NCT00074061
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08