Clinical trial · Interventional
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ
A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ (DCIS)
NCT01060345CI-TRIAL-00044577terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drug no longer available
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polyphenon E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women with Ductal Carcinoma in Situ
- description
- Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E
- interventionNames
- Drug: Polyphenon E
Primary outcomes (1)
- measure
- Percent Change in K167 Staining
- timeFrame
- Prior to starting study and after 4-6 weeks of treatment
Secondary outcomes (6)
- measure
- Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.
- timeFrame
- Prior to study start and 4-6 weeks after treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.