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NCT00548184 · ClinicalTrials.gov registry record · Phase 2

Lapatinib and Trastuzumab With or Without Endocrine Therapy

A Phase 2 study of Breast Cancer, sponsored by Baylor Breast Care Center.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target
6
Study locations

NCT00548184 is a Phase 2 study of Breast Cancer that has completed, run by Baylor Breast Care Center. The registered enrollment target is 65 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 6 states.

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The verdict

NCT00548184, a Phase 2 study of Breast Cancer, has completed, sponsored by Baylor Breast Care Center.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target
6
Study locations

Study Summary

We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors. The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Trastuzumab
  • DRUG Lapatinib
  • DRUG Endocrine

Study Locations (6)

Alabama

  • UAB Cancer Center - Birmingham

Illinois

  • The University of Chicago - Chicago

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bunting-Blaustein Cancer Research - Baltimore

Minnesota

  • Mayo Clinic Cancer Center - Rochester

Tennessee

  • Vanderbilt-Ingram Cancer Center - Nashville

Texas

  • Baylor College of Medicine, Lester and Sue Smith Breast Center - Houston

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2008-05
Est. Completion 2014-01
Phase Phase 2

Sponsor

Baylor Breast Care Center

15 total trials

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What the Registry Record Tells You About NCT00548184

The ClinicalTrials.gov registry entry for NCT00548184 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Baylor Breast Care Center, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.

NCT00548184 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Illinois, Maryland.

Frequently Asked Questions

What is clinical trial NCT00548184 about?

NCT00548184 is a clinical study titled "Lapatinib and Trastuzumab With or Without Endocrine Therapy". We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib pl...

What is the current status of trial NCT00548184?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2008-05. Estimated completion is 2014-01.

What conditions does trial NCT00548184 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00548184?

The interventions under investigation include: Trastuzumab (DRUG), Lapatinib (DRUG), Endocrine (DRUG).

Who is sponsoring clinical trial NCT00548184?

This trial is sponsored by Baylor Breast Care Center, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00548184 being conducted?

This trial has 6 study locations across Alabama, Illinois, Maryland, Minnesota, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.