6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00826267

Run by

Boehringer Ingelheim

People needed

29

Starts

2009-01-01

Last updated by the study team

2013-12-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female, age 18 years or older.
• Histologically proven breast cancer who have not received any prior therapy.
• Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
• HER2-positive.

You may not qualify if…

• Absolute neutrophil count (ANC) less than 1500/mm3.
• Platelet count less than 100 000/ mm3.
• Hemoglobin level less than 9.0 g/dl.
• Bilirubin greater than 1.5 mg/dI.
• Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
• Serum creatinine greater than 1.5 times of the upper normal limit.
• Significant or recent acute gastrointestinal disorders with diarrhea
• Pregnancy or breast-feeding.
• Organ system dysfunction including cardiac (LVEF < 50%).
• Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
• Other malignancies diagnosed within the past five years.
• Serious active infection. HIV, active hepatitis B or C.

Where it is running

• 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

Full record on ClinicalTrials.gov

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