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NCT00826267 · ClinicalTrials.gov registry record · Phase 2

6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

A Phase 2 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT00826267: Completed Phase 2 study, sponsored by Boehringer Ingelheim.

NCT00826267 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00826267, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.

Primary Outcome

Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.

Interventions

  • DRUG trastuzumab
  • DRUG lapatinib
  • DRUG BIBW 2992

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2009-01
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT00826267 record still lists

NCT00826267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

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

NCT00826267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00826267 about?

NCT00826267 is a clinical study titled "6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab". An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and ph...

What is the current status of trial NCT00826267?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2009-01.

What interventions are being tested in trial NCT00826267?

The interventions under investigation include: trastuzumab (DRUG), lapatinib (DRUG), BIBW 2992 (DRUG).

Who is sponsoring clinical trial NCT00826267?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00826267's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 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 NCT00826267, the US trial registry maintained by the National Library of Medicine. NCT00826267 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.