Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized phase I trial studies the side effects and best dose of defined green tea catechin extract in treating women with hormone receptor-negative stage I-III breast cancer. Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborator: National Institutes of Health (NIH)
• Treatments: Epigallocatechin gallate; Hormones

Criteria

Criteria:

• History of histologically confirmed stage I, II, or III breast carcinoma without evidence of disease at study entry

• No evidence of recurrent disease (patients with resected local recurrence are eligible)

• 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

• Menopausal status: Pre- or postmenopausal

• ECOG performance status < 2 (Karnofsky > 60%)

• Leukocytes >= 3,000/uL

• Absolute neutrophil count >= 1,500/uL

• Platelets >= 100,000/uL

• 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 history of gastrointestinal bleeding including, but not limited to, any of the following: Diverticulosis; Peptic ulcer disease; Erosive gastritis; Varices

• 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

• At least 6 months since prior chemotherapy, radiation therapy, and/or breast surgery

• No prior radiation therapy or implant in 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