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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
lapatinib tablets 1500 mg daily
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
1200.44.01001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1200.44.12008 Boehringer Ingelheim Investigational Site
Brasília, Brazil
Objective Response (OR)
Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
Time frame: Tumour assessments were performed at screening, day 22 and day 43.
Number of Participants Who Achieved Clinical Benefit (CB)
CB was defined as CR, PR or stable disease (SD) and was assessed according to RECIST criteria regardless of treatment status.
Time frame: Tumour assessments were performed at screening, day 22 and day 43.
Change From Baseline in the Diameter of the Primary Target Lesion.
Change was based on the primary lesion only rather that the sum of the target lesions as most patients had only one lesion.
Time frame: 3 weeks or 6 weeks
Plasma Concentration of Afatinib
Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
Time frame: Day 7
Changes in Biomarker in Tumour Biopsies
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.
Time frame: Screening, day 22, day 43
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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
Goiânia, Brazil
1200.44.12005 Boehringer Ingelheim Investigational Site
Ijuí, 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
...and 7 more locations