Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00676793
Eligibility Criteria:
Inclusion Criteria:
* Definitive biopsy demonstrating primary breast cancer
* Residual breast cancer requiring additional surgical resection
* Stage I, II or III disease
* Patient has ability to give signed informed consent
* Normal hepatic and renal function (creatinine\<1.5, transaminases \<1.5 times upper limit of normal).
* ECOG Performance status of 0 or 1.
* Age ≥ 21 years and less than 75
Exclusion Criteria:
* Prior hormonal or surgical therapy for breast cancer
* Abnormal liver function test
* Liver or kidney problems that would interfere with metabolism of study drug
* Any condition that would hamper informed consent or ability to comply with study protocol
* Participation in another research study in the last three months
* Known malignancy at any site other than breast
* Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
* Allergy or intolerance to any component of green tea
* Inability or refusal to comply with definitive surgical therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT00676793
Study Brief:
Protocol Section:
NCT00676793