6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
NCT ID: NCT00826267
Last Updated: 2013-12-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2009-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
Lapatinib
Lapatinib tablets 1500 mg daily.
lapatinib
lapatinib tablets 1500 mg daily
Trastuzumab
Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.
trastuzumab
trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
lapatinib
lapatinib tablets 1500 mg daily
BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
trastuzumab
trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically proven breast cancer who have not received any prior therapy.
3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
4. HER2-positive.
Exclusion Criteria
2. Platelet count less than 100 000/ mm3.
3. Hemoglobin level less than 9.0 g/dl.
4. Bilirubin greater than 1.5 mg/dI.
5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
6. Serum creatinine greater than 1.5 times of the upper normal limit.
7. Significant or recent acute gastrointestinal disorders with diarrhea
8. Pregnancy or breast-feeding.
9. Organ system dysfunction including cardiac (LVEF \< 50%).
10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
11. Other malignancies diagnosed within the past five years.
12. Serious active infection. HIV, active hepatitis B or C.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1200.44.01001 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1200.44.12008 Boehringer Ingelheim Investigational Site
Brasília, , 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
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
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1200.44
Identifier Type: -
Identifier Source: org_study_id