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NCT00834678 · ClinicalTrials.gov registry record · Phase 1

Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

A Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
11
Enrollment target

NCT00834678: Completed Phase 1 study, sponsored by Ohio State University Comprehensive Cancer Center.

NCT00834678 is a Phase 1 study that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00834678, a Phase 1 study, has completed, sponsored by Ohio State University Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.

Primary Outcome

28 day cycle included intravenous bendamustine on days 1 and 2.

Interventions

  • DRUG bendamustine
  • DRUG erlotinib
  • DRUG Maintenance erlotinib

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2009-04
Est. Completion 2014-09
Phase Phase 1

What the finished NCT00834678 record still lists

NCT00834678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

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

NCT00834678 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00834678 about?

NCT00834678 is a clinical study titled "Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer". RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking bl...

What is the current status of trial NCT00834678?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2009-04. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00834678?

The interventions under investigation include: bendamustine (DRUG), erlotinib (DRUG), Maintenance erlotinib (DRUG).

Who is sponsoring clinical trial NCT00834678?

This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00834678's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 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 NCT00834678, the US trial registry maintained by the National Library of Medicine. NCT00834678 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.