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NCT00544804 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer and Metastatic Cancer, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
41
Enrollment target
1
Study location

NCT00544804: Completed Phase 1 study of Breast Cancer and Metastatic Cancer, sponsored by University of California, San Francisco.

NCT00544804 is a Phase 1 study of Breast Cancer and Metastatic Cancer that has completed, run by University of California, San Francisco. The registered enrollment target is 41 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00544804, a Phase 1 study of Breast Cancer and Metastatic Cancer, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
41 participants
Enrollment target
1
Study location

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.

Primary Outcome

Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer

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

What the finished NCT00544804 record still lists

NCT00544804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

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.

NCT00544804 reports a single indexed study location in California.

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.

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).

Who is sponsoring clinical trial NCT00544804?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00544804's enrollment target sits among peer trials

41 870th of 1224 higher than 350 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer 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 NCT00544804, the US trial registry maintained by the National Library of Medicine. NCT00544804 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.