NCT01441596

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

Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-02-01
• Completion: 2014-08-01
• First posted: 2011-09-27
• Last updated: 2015-09-07
• Results posted: 2015-02-25

Locations

40 sites across 8 countries: United States, Canada, Finland, France, Germany, Italy, South Korea, Spain