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Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Breast Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • 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.
  • Exclusion criteria:
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00826267

    Start Date

    January 1 2009

    Last Update

    December 31 2013

    Active Locations (17)

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    Page 1 of 5 (17 locations)

    1

    1200.44.01001 Boehringer Ingelheim Investigational Site

    Houston, Texas, United States

    2

    1200.44.12008 Boehringer Ingelheim Investigational Site

    Brasília, Brazil

    3

    1200.44.12011 Boehringer Ingelheim Investigational Site

    Cachoeiro de Itapemirim, Brazil

    4

    1200.44.12012 Boehringer Ingelheim Investigational Site

    Campo Grande, Brazil