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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.