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 | Biotech Hunter

Enrollment

121

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

February 28, 2014

Study Completion Date

August 31, 2014

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

DRUG

Vinorelbine

Vinorelbine 25 mg/mÂ² 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.

Trial Locations (40)

Unknown

1200.67.10106 Boehringer Ingelheim Investigational Site, Bakersfield

1200.67.10105 Boehringer Ingelheim Investigational Site, Fullerton

1200.67.10001 Boehringer Ingelheim Investigational Site, Los Angeles

1200.67.10108 Boehringer Ingelheim Investigational Site, Santa Barbara

1200.67.10003 Boehringer Ingelheim Investigational Site, Lake Success

1200.67.10004 Boehringer Ingelheim Investigational Site, Columbus

1200.67.11004 Boehringer Ingelheim Investigational Site, Toronto

1200.67.11003 Boehringer Ingelheim Investigational Site, Greenfield Park

1200.67.11002 Boehringer Ingelheim Investigational Site, Montreal

1200.67.35801 Boehringer Ingelheim Investigational Site, Helsinki

1200.67.35802 Boehringer Ingelheim Investigational Site, Tampere

1200.67.35803 Boehringer Ingelheim Investigational Site, Turku

1200.67.33009 Boehringer Ingelheim Investigational Site, Caen

1200.67.33010 Boehringer Ingelheim Investigational Site, Clermont-Ferrand

1200.67.33008 Boehringer Ingelheim Investigational Site, Lille

1200.67.33001 Boehringer Ingelheim Investigational Site, Lyon

1200.67.33004 Boehringer Ingelheim Investigational Site, Marseille

1200.67.33011 Boehringer Ingelheim Investigational Site, Nice

1200.67.33002 Boehringer Ingelheim Investigational Site, Paris

1200.67.33003 Boehringer Ingelheim Investigational Site, Paris

1200.67.33012 Boehringer Ingelheim Investigational Site, Saint-Cloud

1200.67.33005 Boehringer Ingelheim Investigational Site, Saint-Herblain

1200.67.49002 Boehringer Ingelheim Investigational Site, Erlangen

1200.67.49008 Boehringer Ingelheim Investigational Site, Essen

1200.67.49005 Boehringer Ingelheim Investigational Site, Hanover

1200.67.49006 Boehringer Ingelheim Investigational Site, Heidelberg

1200.67.49007 Boehringer Ingelheim Investigational Site, MÃ¼nchen

1200.67.49003 Boehringer Ingelheim Investigational Site, Oldenburg

1200.67.49004 Boehringer Ingelheim Investigational Site, TÃ¼bingen

1200.67.39001 Boehringer Ingelheim Investigational Site, Modena

1200.67.39002 Boehringer Ingelheim Investigational Site, Reggio Emilia

1200.67.82001 Boehringer Ingelheim Investigational Site, Goyang

1200.67.82002 Boehringer Ingelheim Investigational Site, Seoul

1200.67.82003 Boehringer Ingelheim Investigational Site, Seoul

1200.67.82004 Boehringer Ingelheim Investigational Site, Seoul

1200.67.34002 Boehringer Ingelheim Investigational Site, Barcelona

1200.67.34006 Boehringer Ingelheim Investigational Site, CÃ³rdoba

1200.67.34005 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat

1200.67.34003 Boehringer Ingelheim Investigational Site, Madrid

1200.67.34004 Boehringer Ingelheim Investigational Site, Valencia