|Inclusion Criteria:||1) History of histologically-confirmed stage I, II, or III estrogen receptor (ER)-negative & progesterone receptor (PR)-negative breast carcinoma w/o evidence of disease at trial entry. Participants w/ a resected local recurrence are eligibile. Less than 10% ER & PR expression is considered negative. Site study physicians will review histology & hormone receptor status from pathology reports (this will be recorded in the Inclusion Criteria CRF). A release of medical records will be obtained to document hx of breast cancer diagnosis, staging, & treatment (this will be captured on the Med Hx CRF).|
2) Minimum of 6 months since last chemotherapy, radiation therapy, and/or breast surgery and no evidence of recurrent disease.
3) Age 21 to 65 years. (Breast cancer is extremely rare in women less than 21 years. The maximum age of 65 years was chosen due to the higher prevalence of hyperplasia and atypia on breast biopsies from young to middle-aged high risk women.) Both pre- and postmenopausal women will be included in this study. Postmenopausal status will be defined as the absence of menses for > 12 months or serum FSH > 20 mIU/ml.
4) Negative pregnancy testing (by serum b-hCG) within 2 wks. of study entry and at month 3 during therapy for women of child-bearing potential. 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. Women will be allowed to be on oral contraceptives, provided they have not changed their dose of these medications for at least 6 months prior to study entry. If a participant does become pregnant while on study, she will be removed from the study.
5) Normal mammogram on contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy.
6) ECOG performance status < 2 (Karnofsky > 60%)
7) Participants must have normal organ and marrow function as defined as: Leukocytes >/= 3,000/mL; Absolute neutrophil count >/= 1,500/mL; Platelets >/= 100,000/mL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT (SGPT) </= institutional ULN; Serum creatinine within normal institutional limits
8) Willingness to abstain from all tea consumption for 30 days prior to baseline evaluation and during the study intervention. Many tea products, including black, green, white, oolong, and pu-erh teas, contain varying amounts of polyphenols. As we believe EGCG (the major polyphenol in green tea) is the active ingredient in Poly E that will affect our biomarker endpoints, we would like to eliminate any use of tea product-based polyphenols by our participants during the 6-month study intervention.
9) Willingness to limit total daily caffeine consumption to < or = to three 8 ounce cups per day for 30 days prior to baseline evaluation and during study intervention. Total daily caffeine consumption shoud not exceed 375 mg/day. Study subjects will be provided a list of permissible medications, beverages, and foods which contain caffeine (Appendix K). Poly E contains only minimal amounts of caffeine. However, doses of up to 1000 mg twice daily of Poly E in combination with dietary caffeine intake may increase the rate of caffeine-related toxicity.
10) Willingness to comply with all study intervention and follow-up procedures.
11) Ability to understand and willingness to sign a written informed consent document.
12) Since breast cancer is exceedingly rare in men, only women will be included in this study. Members of all races and ethnic groups are eligible for this trial.