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Brief Title: 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Official Title: Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
Study ID: NCT00826267
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
1200.44.01001 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
1200.44.12008 Boehringer Ingelheim Investigational Site, Brasilia, , Brazil
1200.44.12011 Boehringer Ingelheim Investigational Site, Cachoeiro de Itapemirim, , Brazil
1200.44.12012 Boehringer Ingelheim Investigational Site, Campo Grande, , Brazil
1200.44.12009 Boehringer Ingelheim Investigational Site, Caxias do Sul, , Brazil
1200.44.12010 Boehringer Ingelheim Investigational Site, Goiania, , Brazil
1200.44.12005 Boehringer Ingelheim Investigational Site, Ijui, , Brazil
1200.44.12007 Boehringer Ingelheim Investigational Site, Natal, , Brazil
1200.44.12004 Boehringer Ingelheim Investigational Site, Novo Hamburgo, , Brazil
1200.44.12001 Boehringer Ingelheim Investigational Site, Porto Alegre, , Brazil
1200.44.12013 Boehringer Ingelheim Investigational Site, Porto Alegre, , Brazil
1200.44.14002 Boehringer Ingelheim Investigational Site, Bogotá, , Colombia
1200.44.14001 Boehringer Ingelheim Investigational Site, Cali, , Colombia
1200.44.19005 Boehringer Ingelheim Investigational Site, Cercado, , Peru
1200.44.19001 Boehringer Ingelheim Investigational Site, Lima, , Peru
1200.44.19004 Boehringer Ingelheim Investigational Site, Lima, , Peru
1200.44.19003 Boehringer Ingelheim Investigational Site, San Isidro, , Peru
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR