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

NCT00826267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-12-31

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

lapatinib

lapatinib tablets 1500 mg daily

DRUG

BIBW 2992

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

DRUG

trastuzumab

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-08-31

Countries

  • United States
  • Brazil
  • Colombia
  • Peru

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826267 on ClinicalTrials.gov