Green Tea and Reduction of Breast Cancer Risk

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Green tea extract contains ingredients (catechins) that may lower the risk of breast cancer.

PURPOSE: This phase II trial is studying how well green tea extract works in preventing breast cancer compared to a placebo in postmenopausal women with high breast density.

The investigators have hypothesized that green tea consumption reduces breast cancer risk, and this effect is seen primarily in women who have the low-activity COMT genotype. The investigators will test this by evaluating the effects of green tea extract on breast cancer biomarkers including mammographic density, plasma insulin-like growth factor 1 (IGF-1), IGF binding protein 3 (IGFBP-3), estrone, estradiol, androstenedione, sex hormone binding globulin (SHBG), urinary estrogen metabolites and plasma F2-isoprostanes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Signed informed consent

• Healthy postmenopausal women aged 50-70 years

• "Heterogeneously dense" (51-75% glandular) or "extremely dense" (>75%glandular) breasts

• Willing to avoid consumption of green tea for 1 year

Exclusion Criteria:

• Positive serological markers of hepatitis B or hepatitis C infections

• Elevated levels of liver enzymes

• Recent (within 6 mo) or current hormone or hormone modification therapy, including systemic hormone replacement therapy, SERMS and aromatase inhibitors

• Current smoker of cigarettes or other tobacco products

• BMI <19 or >40 kg/m2

• Weight change > 10 lbs during the previous year

• History of breast cancer or proliferative breast disease

• Regular consumption of > 7 alcoholic drinks/wk

• Regular consumption of green tea (>1 cup/wk)

• Recent (within 6 mo) or current use of chemopreventive agents such as tamoxifen, raloxifene or aromatase inhibitors

• Participation in any weight loss or weight gain studies

• Currently taking Methotrexate or Enbrel

• History of ovarian cancer

• Any form of cancer in the last 5 years

• Presence of implants