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NCT00499681 · ClinicalTrials.gov registry record · Phase 2

PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE

A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.

Terminated
Registry status
Phase 2
Development phase
6
Enrollment target

NCT00499681 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 6 participants.

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The verdict

NCT00499681, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast cancer that can be removed by surgery.

Interventions

  • OTHER placebo
  • DRUG letrozole
  • DRUG lapatinib ditosylate

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-07
Est. Completion 2010-12
Phase Phase 2

Sponsor

Vanderbilt-Ingram Cancer Center

189 total trials

What the Registry Record Tells You About NCT00499681

The ClinicalTrials.gov registry entry for NCT00499681 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.

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

NCT00499681 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00499681 about?

NCT00499681 is a clinical study titled "PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE". RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together w...

What is the current status of trial NCT00499681?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-07. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00499681?

The interventions under investigation include: placebo (OTHER), letrozole (DRUG), lapatinib ditosylate (DRUG).

Who is sponsoring clinical trial NCT00499681?

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

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.