A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Stopped early · Phase 2

Conditions studied: Ductal Carcinoma in Situ

In brief

The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).

Key facts

Study ID

NCT01060345

Run by

University of Chicago

People needed

20

Starts

2010-05-01

Expected to finish

2015-09-01

Last updated by the study team

2020-04-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed DCIS by breast core biopsy with a corresponding lesion on breast MRI of at least 1-cm3 in volume.
• Patients may have undergone treatment with prior chemotherapy if this was greater than 12 months prior to current diagnosis.
• Age >18 years.
• ECOG performance status <2 (Karnofsky >60%)
• Life expectancy of greater than 12 months.
• Normal organ and marrow function as defined below:
• leukocytes >3,000/mcL
• absolute neutrophil count >1,500/mcL
• platelets >100,000/mcL
• total bilirubin within normal institutional limits
• AST(SGOT) \& ALT(SGPT)within normal institutional limits
• creatinine <1.5 times institutional upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Pregnancy
• Patients who have undergone prior excisional biopsy for DCIS.
• Patients who are unable to undergo MRI due to claustrophobia or other reason.
• Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study.
• Patients receiving any other chemotherapy or investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extracts or sensitivity to green tea.
• Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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