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NCT00033514 · ClinicalTrials.gov registry record · Phase 1

Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

A Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT00033514: Completed Phase 1 study, sponsored by Jonsson Comprehensive Cancer Center.

NCT00033514 is a Phase 1 study that has completed, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00033514, a Phase 1 study, has completed, sponsored by Jonsson Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Primary Outcome

Complete Response: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Partial Response: A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.

Interventions

  • BIOLOGICAL trastuzumab
  • DRUG erlotinib hydrochloride

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2001-08
Est. Completion 2011-12
Phase Phase 1
Jonsson Comprehensive Cancer Center

321 total trials

What the finished NCT00033514 record still lists

NCT00033514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which trastuzumab is the first listed.

NCT00033514 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00033514 about?

NCT00033514 is a clinical study titled "Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression". RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining t...

What is the current status of trial NCT00033514?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2001-08. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00033514?

The interventions under investigation include: trastuzumab (BIOLOGICAL), erlotinib hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00033514?

This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00033514's enrollment target sits among peer trials

27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00033514, the US trial registry maintained by the National Library of Medicine. NCT00033514 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.