NCT00676793

Brief Summary

To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started May 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 26, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 21, 2017

Status Verified

August 1, 2017

Enrollment Period

5.6 years

First QC Date

May 9, 2008

Results QC Date

September 2, 2011

Last Update Submit

August 23, 2017

Conditions

Breast Cancer

Keywords

breast cancerEGCGPolyphenon Ec-MetVEGFHGF

Outcome Measures

Primary Outcomes (2)

  • Change in Serum VEGF in Breast Cancer

    Change in serum VEGF from baseline to post treatment with polyphenon E.

    Baseline and 4 to 6 weeks

  • Change in Serum HGF and Breast Cancer

    Change in serum HGF from baseline to post Polyphenol E treatment.

    Baseline and 4 to 6 weeks

Study Arms (1)

Polyphenon E

EXPERIMENTAL

This is a single arm study comparing changes within patients before and after receiving the experimental drug Polyphenon E for the duration of the study, between recruitment and surgery for breast cancer.

Drug: Polyphenon E

Interventions

Polyphenon EDRUG

Four 200mg capsules daily taken with a meal, for the duration of the study.

Polyphenon E

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Proffered Oral Presentations - Intervention Studies Abstract PR-05: Effects of presurgical administration of tea polyphenols in women with operable breast cancer Julie L. Campbell1, James Cardelli2, Jerry McLarty2, Dawn Hershman1, Bret Taback1, Susan Refice1, Stephanie Wang2, Rebecca Bigelow2 and Katherine Crew1 1Columbia University Medical Center, New York, NY 2Louisiana State University Health Sciences Center, Shreveport, LA Cancer Prevention Research: December 2010; Volume 3, Issue 12, Supplement 2. doi: 10.1158/1940-6207.PREV-10-PR-05

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Jerry w. McLarty, Ph.D.
Organization
LSU Health, Shreveport
jmclar@lsuhsc.edu
(318)813-1446

Study Officials

  • Gary Burton, M.D.

    LSU Health Sciences Center Shreveport

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

May 1, 2004

Primary Completion

December 1, 2009

Study Completion

July 1, 2013

Last Updated

September 21, 2017

Results First Posted

October 26, 2012

Record last verified: 2017-08

Locations

US(2)