NCT01060345

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

5.3 years

First QC Date

January 29, 2010

Results QC Date

March 12, 2020

Last Update Submit

April 6, 2020

Conditions

Ductal Carcinoma in Situ

Keywords

DCIS

Outcome Measures

Primary Outcomes (1)

  • Percent Change in K167 Staining

    Prior to starting study and after 4-6 weeks of treatment

Secondary Outcomes (6)

  • Decrease in MRI Volume and Signal Enhancement Ratio (SER) of the Breast Lesion From Pre- to Post-treatment.

    Prior to study start and 4-6 weeks after treatment

  • Change in Percent Staining of CD68 in Breast Tissue

    Prior to study start and 4-6 weeks after treatment

  • Change in Percent Staining of CD31 in Breast Tissue

    Prior to study start and 4-6 weeks after treatment

  • Change in Percent Staining of VEGF in Breast Tissue

    Prior to study start and after 4-6 weeks of treatment

  • Change in Serum Levels of IGF-1

    Prior to study start and after 4-6 weeks of treatment

  • +1 more secondary outcomes

Study Arms (1)

Women with Ductal Carcinoma in Situ

EXPERIMENTAL

Women who have been diagnosed with ductal carcinoma in situ (DCIS) and will be taking Polyphenon E

Drug: Polyphenon E

Interventions

Polyphenon EDRUG

three 200mg capsules (600mg total dose of the study drug) with food (within one hour of eating a substantial meal) daily for a minimum of 4 weeks, or until the day before surgery

Also known as: Green tea
Women with Ductal Carcinoma in Situ

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

polyphenon ETea

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Nora Jaskowiak, MD
Organization
University of Chicago
njaskowi@surgery.bsd.uchicago.edu
773-702-2048

Study Officials

  • Nora Jaskowiak, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 9, 2020

Results First Posted

April 9, 2020

Record last verified: 2020-03

Locations

US(1)