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NCT00099008 · ClinicalTrials.gov registry record · Phase 1

Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women

A Phase 1 study of Breast Cancer and Endometrial Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT00099008: Completed Phase 1 study of Breast Cancer and Endometrial Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT00099008 is a Phase 1 study of Breast Cancer and Endometrial Cancer that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00099008, a Phase 1 study of Breast Cancer and Endometrial Cancer, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial cancer. PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women.

Primary Outcome

Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Genistein

Study Locations (1)

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-03
Est. Completion 2006-07
Phase Phase 1

What the finished NCT00099008 record still lists

NCT00099008 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00099008 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT00099008 about?

NCT00099008 is a clinical study titled "Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women". RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial cancer. PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing...

What is the current status of trial NCT00099008?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-03. Estimated completion is 2006-07.

What conditions does trial NCT00099008 study?

This clinical trial studies the following conditions: Breast Cancer, Endometrial Cancer.

What interventions are being tested in trial NCT00099008?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Genistein (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT00099008?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00099008 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00099008's enrollment target sits among peer trials

30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00099008, the US trial registry maintained by the National Library of Medicine. NCT00099008 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.