Green Tea and Reduction of Breast Cancer Risk

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00917735

Run by

University of Minnesota

People needed

1075

Starts

2009-07-01

Expected to finish

2014-06-01

Last updated by the study team

2016-02-22

Who can join

Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fairview Southdale Breast Center — Edina, Minnesota, United States
• Fairview Maple Grove Breast Center — Maple Grove, Minnesota, United States
• University of Minnesota Medical Center (UMMC) Breast Clinic — Minneapolis, Minnesota, United States
• Park Nicollet Institute — Saint Louis Park, Minnesota, United States
• Food Science and Nutrition, University of Minnesota — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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