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LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

NCT01125566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2019-07-18

Study results available
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Summary

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Conditions

  • Breast Neoplasms

Interventions

DRUG

BIBW 2992

patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management

DRUG

trastuzumab

patients receive trastuzumab 2mg/kg intravenously every week

DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

DRUG

vinorelbine

patients receive vinorelbine 25mg/m² intravenously every week

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
2010-06-22
Primary Completion
2013-06-08
Completion
2018-07-06

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Egypt
  • France
  • Germany
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lebanon
  • Lithuania
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Russia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Sri Lanka
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT01125566 on ClinicalTrials.gov