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COMPLETED Phase 1

Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2

NCT00544804 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.

Interventions

  • GENETIC gene expression analysis
  • OTHER diagnostic laboratory biomarker analysis
  • DRUG lapatinib ditosylate

Study Locations (1)

California

  • UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2007-08
Est. Completion 2013-12
Phase Phase 1

Sponsor

University of California, San Francis

1,574 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00544804

The ClinicalTrials.gov registry entry for NCT00544804 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which gene expression analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00544804 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00544804 about?

NCT00544804 is a clinical study titled "Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2". RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.

What is the current status of trial NCT00544804?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2007-08. Estimated completion is 2013-12.

What conditions does trial NCT00544804 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00544804?

The interventions under investigation include: gene expression analysis (GENETIC), diagnostic laboratory biomarker analysis (OTHER), lapatinib ditosylate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00544804?

This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00544804 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial