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NCT00516243 · ClinicalTrials.gov registry record · Phase 1

Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer

A Phase 1 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
4
Study locations

NCT00516243 is a Phase 1 study of Stage II Breast Cancer and Stage IIIA Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 318-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT00516243, a Phase 1 study of Stage II Breast Cancer and Stage IIIA Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
4
Study locations

Study Summary

This randomized phase I trial studies the side effects and best dose of defined green tea catechin extract in treating women with hormone receptor-negative stage I-III breast cancer. Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

Interventions

  • OTHER placebo
  • OTHER quality-of-life assessment
  • PROCEDURE laboratory biomarker analysis
  • PROCEDURE questionnaire administration
  • DRUG defined green tea catechin extract

Study Locations (4)

New York

  • Columbia University Medical Center - New York
  • Memorial Sloan-Kettering Cancer Center - New York

Texas

  • Baylor College of Medicine - Houston
  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2007-07
Est. Completion 2010-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00516243

The ClinicalTrials.gov registry entry for NCT00516243 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 318-participant average among 30 other Stage II Breast Cancer trials with a reported enrollment target (87% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 6 conditions, with Stage II Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.

NCT00516243 reports 4 study locations spanning 2 distinct geographic areas - top geographies include New York, Texas.

Frequently Asked Questions

What is clinical trial NCT00516243 about?

NCT00516243 is a clinical study titled "Defined Green Tea Catechin Extract in Treating Women With Hormone Receptor Negative Stage I-III Breast Cancer". This randomized phase I trial studies the side effects and best dose of defined green tea catechin extract in treating women with hormone receptor-negative stage I-III breast cancer. Green tea extract contains ingredients that may prevent or slow the growth of breast cancer.

What is the current status of trial NCT00516243?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-07. Estimated completion is 2010-03.

What conditions does trial NCT00516243 study?

This clinical trial studies the following conditions: Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage I Breast Cancer, Estrogen Receptor-negative Breast Cancer.

What interventions are being tested in trial NCT00516243?

The interventions under investigation include: placebo (OTHER), quality-of-life assessment (OTHER), laboratory biomarker analysis (PROCEDURE), questionnaire administration (PROCEDURE), defined green tea catechin extract (DRUG).

Who is sponsoring clinical trial NCT00516243?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00516243 being conducted?

This trial has 4 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.