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NCT00054132 · ClinicalTrials.gov registry record · Phase 2

Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
38
Enrollment target

NCT00054132: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00054132 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00054132, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study Summary

This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer.

Primary Outcome

Estimated at the end of the trial Immunoreactivity will be evaluated qualitatively with regard to intensity as follows: Measured on a scale, ranging from 0-3+ 0=negative (no immunoreactivity) 1+ - 3+ = positive: * faint immunoreactivity (weak staining) * intense immunoreactivity (strong staining) Immunohistochemical studies will be performed on the tumor specimen to correlate the anti-tumor efficacy of OSI-774 and bevacizumab with pre-treatment molecular characteristics.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Bevacizumab
  • DRUG Erlotinib Hydrochloride

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2002-12
Est. Completion 2015-04
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00054132 record still lists

NCT00054132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

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

NCT00054132 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00054132 about?

NCT00054132 is a clinical study titled "Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer". This phase II trial studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may inter...

What is the current status of trial NCT00054132?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2002-12. Estimated completion is 2015-04.

What interventions are being tested in trial NCT00054132?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Erlotinib Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00054132?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00054132's enrollment target sits among peer trials

38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00054132, the US trial registry maintained by the National Library of Medicine. NCT00054132 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.