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Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

NCT01441596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2015-09-07

Study results available
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Summary

The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Conditions

  • Breast Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

Vinorelbine

Vinorelbine 25 mg/m² on days 1, 8, 15 in a 3-weekly course

DRUG

Investigator's choice of treatment

Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.

DRUG

afatinib

Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.

DRUG

afatinib

Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.

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
2011-10-31
Primary Completion
2014-02-28
Completion
2014-08-31

Countries

  • United States
  • Canada
  • Finland
  • France
  • Germany
  • Italy
  • South Korea
  • Spain

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 NCT01441596 on ClinicalTrials.gov