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 IIIA breast cancer.
Ages Eligible for Study: 21 Years - 65 Years, Genders Eligible for Study: Female
Criteria
DISEASE CHARACTERISTICS:
History of histologically confirmed stage I, II, or IIIA breast carcinoma without evidence of disease at study entry
No evidence of recurrent disease
Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy
No history of histologically confirmed bilateral breast cancer
No evidence of metastatic breast cancer
Registered in the outpatient medical oncology clinic at Columbia University Medical Center (CUMC), MD Anderson Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), or the Weill-Cornell campus of New York Presbyterian Hospital (NYP-WC)
Hormone receptor status:
Estrogen- and progesterone-receptor negative
PATIENT CHARACTERISTICS:
Female
Menopausal status:
Pre- or postmenopausal
ECOG performance status < 2 (Karnofsky > 60%)
Leukocytes ≥ 3,000/μL
Absolute neutrophil count ≥ 1,500/μL
Platelets ≥ 100,000/μL
Total bilirubin within normal institutional limits
AST/ALT ≤ 2.5 times institutional upper limit of normal
Serum creatinine within normal institutional limits
Not pregnant or nursing
Negative pregnancy test
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract (Polyphenon E), such as green tea food products or supplements containing EGCG
No uncontrolled or significant co-morbid illness including, but not limited to, any of the following:
Active or serious infection requiring intravenous antibiotics
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Active gastrointestinal bleeding
Active liver disease
Psychiatric illness/social situations that would limit compliance with study requirements
No active malignancy, except for squamous cell carcinoma of the skin; basal cell carcinoma of the skin; carcinoma in situ; stage IA or IB invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy; or stage IA grade 1 adenocarcinoma of the endometrium treated by surgery
PRIOR CONCURRENT THERAPY:
At least 6 months since prior chemotherapy, radiation therapy, and/or breast surgery
No prior radiation therapy to the contralateral breast
More than 30 days since prior and no concurrent medications, herbs, or vitamin and mineral supplements that contain tea compounds or caffeine
At least 30 days since prior and no other concurrent investigational agents
At least 30 days since prior and no concurrent tea consumption
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
Total daily caffeine consumption should not exceed 375 mg/day
No concurrent hormone replacement therapy, tamoxifen, or raloxifene
Concurrent oral contraceptives allowed provided the dose has not been changed for at least 6 months prior to study entry
No concurrent chemotherapy or radiation therapy
Location and Contact Information
Trial Lead Organizations
M. D. Anderson Cancer Center at University of Texas
Scott Lippman, MD, FACP, Principal investigator
Ph: 713-745-5439; 800-392-1611
Please refer to this study by ClinicalTrials.gov identifier NCT00516243
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, 10032, United States; Recruiting
Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615
Memorial Sloan - Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 646-888-4551
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848
United States, Texas
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4095, United States; Recruiting
Scott M. Lippman, MD, FACP 713-745-3672
Study chairs or principal investigators
Scott M. Lippman, MD, FACP, Principal Investigator, M.D. Anderson Cancer Center
Study ID Numbers: CDR0000557580; MDA-MDA04-4-01
Last Updated: August 21, 2007
Record first received: August 14, 2007
ClinicalTrials.gov Identifier: NCT00516243
Health Authority: Unspecified
