CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
lapatinib +2 moredrug
Likely dose
lapatinib 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00826267
NCT00826267Phase 2Completed
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Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients

Boehringer Ingelheim·interventional·Posted Jan 22, 2009·Updated Dec 31, 2013

In Brief

A Phase 2 clinical trial evaluating lapatinib, BIBW 2992, and 1 other intervention for Breast Neoplasms. Completed, enrolled 29 participants across 17 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesBrazil, Colombia, Peru, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2009
Enrollment StartJan 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.4 years ago

Interventions

lapatinibdrug

lapatinib tablets 1500 mg daily

BIBW 2992drug

BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)

trastuzumabdrug

trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly