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NCT00005879 · ClinicalTrials.gov registry record · Phase 2

LY353381 in Preventing Breast Cancer in Women With Hyperplasia

A Phase 2 study, sponsored by University of Kansas Medical Center.

Completed
Registry status
Phase 2
Development phase
199
Enrollment target

NCT00005879: Completed Phase 2 study, sponsored by University of Kansas Medical Center.

NCT00005879 is a Phase 2 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 199 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005879, a Phase 2 study, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
199 participants
Enrollment target

Study Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia. PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.

Primary Outcome

Change in the semi-quantitative score assigned by the designated cytopathologist. Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.

Interventions

  • DRUG Placebo
  • DRUG arzoxifene

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2000-08
Est. Completion 2008-07
Phase Phase 2
University of Kansas Medical Center

408 total trials

What the finished NCT00005879 record still lists

NCT00005879 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00005879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005879 about?

NCT00005879 is a clinical study titled "LY353381 in Preventing Breast Cancer in Women With Hyperplasia". RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia. PURPOSE: Randomized phase II trial to study the effectiven...

What is the current status of trial NCT00005879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2000-08. Estimated completion is 2008-07.

What interventions are being tested in trial NCT00005879?

The interventions under investigation include: Placebo (DRUG), arzoxifene (DRUG).

Who is sponsoring clinical trial NCT00005879?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00005879's enrollment target sits among peer trials

199 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00005879, the US trial registry maintained by the National Library of Medicine. NCT00005879 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.