6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT00826267
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lapatinib lapatinib Lapatinib tablets 1500 mg daily. Trastuzumab trastuzumab Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly. BIBW 2992 BIBW 2992 BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
- Primary Outcome Measures
Name Time Method Objective Response (OR) Tumour assessments were performed at screening, day 22 and day 43. Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Achieved Clinical Benefit (CB) Tumour assessments were performed at screening, day 22 and day 43. CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.
Plasma Concentration of Afatinib Day 7 Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
Changes in Biomarker in Tumour Biopsies Screening, day 22, day 43 Changes in the biomarkers (Phospho-MAP-Kinase (MAPK), Total MAPK expression, EGFR, HER2, Phospho-EGFR and -HER2, Proliferation marker (Ki67 and p27), Apoptotic index (cleaved caspase 3), Phosphate and tensin homolog (PTEN), HER2 homodimerisation by HERmark assay and Phospho AKT) from biopsy tissue.
Change From Baseline in the Diameter of the Primary Target Lesion. 3 weeks or 6 weeks Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.
Trial Locations
- Locations (17)
1200.44.01001 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
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
1200.44.19005 Boehringer Ingelheim Investigational Site
🇵🇪Cercado, Peru
1200.44.19001 Boehringer Ingelheim Investigational Site
🇵🇪Lima, Peru
1200.44.12013 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1200.44.19004 Boehringer Ingelheim Investigational Site
🇵🇪Lima, Peru
1200.44.19003 Boehringer Ingelheim Investigational Site
🇵🇪San Isidro, Peru
1200.44.12008 Boehringer Ingelheim Investigational Site
🇧🇷Brasilia, Brazil
1200.44.12012 Boehringer Ingelheim Investigational Site
🇧🇷Campo Grande, Brazil
1200.44.12001 Boehringer Ingelheim Investigational Site
🇧🇷Porto Alegre, Brazil
1200.44.12010 Boehringer Ingelheim Investigational Site
🇧🇷Goiania, Brazil
1200.44.12011 Boehringer Ingelheim Investigational Site
🇧🇷Cachoeiro de Itapemirim, Brazil
1200.44.12009 Boehringer Ingelheim Investigational Site
🇧🇷Caxias do Sul, Brazil
1200.44.14002 Boehringer Ingelheim Investigational Site
🇨🇴Bogotá, Colombia
1200.44.14001 Boehringer Ingelheim Investigational Site
🇨🇴Cali, Colombia