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Green Tea Supplement in Women With Incident Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Incident Breast Cancer

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Trial Information

Green Tea Supplement in Women With Incident Breast Cancer

Inclusion Criteria:

- Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if
prior hysterectomy

- Non-current (not with past 6 months) user of menopausal hormones

- Mammographic abnormality consistent with any type of incident breast cancer
necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw
baseline LFT and complete screening questionnaire. Unless the biopsy confirms
incident breast cancer, such subjects will not be included in further research
interventions and they will not serve as EGCG treated or control subjects.

- Diagnosed with incident breast cancer on the diagnostic biopsy is required for
inclusion in the EGCG or control treatment groups.

- Non-green tea drinker (less than monthly) - this criteria does not apply to black tea
or herbal tea

- Provided written informed consent

Exclusion Criteria:

- Green tea drinker (once per month or more)

- History of breast cancer or other cancer including a prior diagnosis of any type of
incident breast cancer.

- Known allergy to tea

- Abnormal liver enzymes (plus or minus 10% of the normal ranges).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

level of reduction in proliferation or increase in apoptosis in association with short-term EGCG

Outcome Time Frame:

At surgery

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

June 2015

Related Keywords:

  • Incident Breast Cancer
  • Postmenopausal women
  • Suspicious for breast ca
  • Breast Neoplasms



USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800