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NCT00651976 · ClinicalTrials.gov registry record · Early Phase 1

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

A Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

Terminated
Registry status
Early Phase 1
Development phase
213
Enrollment target

NCT00651976: Clinical Trial Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.

NCT00651976 is a Early Phase 1 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 213 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00651976, a Early Phase 1 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.

TERMINATED
Registry status
Early Phase 1
Development phase
213 participants
Enrollment target

Study Summary

RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of letrozole on the tumor on a molecular level and determine markers of response to treatment. PURPOSE: This study will show us how well letrozole works in treating postmenopausal women with stage I, II or III breast cancer that can be removed by surgery.

Primary Outcome

Ki67 index is measured by counting the percentage of cells staining for Ki67 in a section of breast tissue. The number of stained cells will be compared in tissue that is hormone receptor-positive tissue to tissue that is hormone receptor negative.

Interventions

  • OTHER Blood Collection
  • DRUG letrozole
  • PROCEDURE biopsy/lumpectomy/mastectomy

Trial Details

FieldValue
Enrollment Target 213 participants
Start Date 2008-03
Est. Completion 2018-09
Phase Early Phase 1
Vanderbilt-Ingram Cancer Center

189 total trials

Why NCT00651976 stopped before completion

NCT00651976 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (302% higher).

The record links to 0 conditions, and to 3 interventions - of which Blood Collection is the first listed.

NCT00651976 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00651976 about?

NCT00651976 is a clinical study titled "Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery". RATIONALE: Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving letrozole before surgery allows us to monitor the effects of letrozole on the tumor on a molecular level and determine markers of response to treatment. PURPOSE: This study w...

What is the current status of trial NCT00651976?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 213 participants. The study started on 2008-03. Estimated completion is 2018-09.

What interventions are being tested in trial NCT00651976?

The interventions under investigation include: Blood Collection (OTHER), letrozole (DRUG), biopsy/lumpectomy/mastectomy (PROCEDURE).

Who is sponsoring clinical trial NCT00651976?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00651976's enrollment target sits among peer trials

213 58th of 2000 higher than 1,943 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT00651976, the US trial registry maintained by the National Library of Medicine. NCT00651976 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.