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OpenTrials
Completed

NCT Number: NCT00826267

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

1200.44.12008 Boehringer Ingelheim Investigational Site, Brasília, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lapatinib

Drug

lapatinib tablets 1500 mg daily

BIBW 2992

Drug

BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)

Trastuzumab

Drug

trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Plasma Concentration of Afatinib

    Time frame: Day 7

    Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7

  4. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients

Important dates

Study start
2009
Primary completion
2011
First posted
Jan 22, 2009
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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