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

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ClinicalTrials.gov Identifier: NCT00826267
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : October 17, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE January 20, 2009
First Posted Date  ICMJE January 22, 2009
Results First Submitted Date  ICMJE August 8, 2013
Results First Posted Date  ICMJE October 17, 2013
Last Update Posted Date December 31, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
Objective Response (OR) [ Time Frame: Tumour assessments were performed at screening, day 22 and day 43. ]
Objective response (complete or partial) was assessed according to RECIST 1.0 criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
Objective response rate [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • Number of Participants Who Achieved Clinical Benefit (CB) [ Time Frame: 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.
  • Change From Baseline in the Diameter of the Primary Target Lesion. [ Time Frame: 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.
  • Plasma Concentration of Afatinib [ Time Frame: Day 7 ]
    Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
  • Changes in Biomarker in Tumour Biopsies [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2009)
Clinical benefit rate, PK, changes in biomarker in tumor biopsies, safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
Official Title  ICMJE Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: lapatinib
    lapatinib tablets 1500 mg daily
  • Drug: BIBW 2992
    BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
  • Drug: trastuzumab
    trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly
Study Arms  ICMJE
  • Experimental: BIBW 2992
    BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
    Intervention: Drug: BIBW 2992
  • Active Comparator: Lapatinib
    Lapatinib tablets 1500 mg daily.
    Intervention: Drug: lapatinib
  • Active Comparator: Trastuzumab
    Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.
    Intervention: Drug: trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2011)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2009)
120
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Female, age 18 years or older.
  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:

  1. Absolute neutrophil count (ANC) less than 1500/mm3.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Colombia,   Peru,   United States
Removed Location Countries Argentina,   Chile,   Costa Rica,   Mexico,   Panama
 
Administrative Information
NCT Number  ICMJE NCT00826267
Other Study ID Numbers  ICMJE 1200.44
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP