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

December 5, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Brasilia, Brazil
        • 1200.44.12008 Boehringer Ingelheim Investigational Site
      • Cachoeiro de Itapemirim, Brazil
        • 1200.44.12011 Boehringer Ingelheim Investigational Site
      • Campo Grande, Brazil
        • 1200.44.12012 Boehringer Ingelheim Investigational Site
      • Caxias do Sul, Brazil
        • 1200.44.12009 Boehringer Ingelheim Investigational Site
      • Goiania, Brazil
        • 1200.44.12010 Boehringer Ingelheim Investigational Site
      • Ijui, Brazil
        • 1200.44.12005 Boehringer Ingelheim Investigational Site
      • Natal, Brazil
        • 1200.44.12007 Boehringer Ingelheim Investigational Site
      • Novo Hamburgo, Brazil
        • 1200.44.12004 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1200.44.12001 Boehringer Ingelheim Investigational Site
      • Porto Alegre, Brazil
        • 1200.44.12013 Boehringer Ingelheim Investigational Site
  • Colombia
      • Bogotá, Colombia
        • 1200.44.14002 Boehringer Ingelheim Investigational Site
      • Cali, Colombia
        • 1200.44.14001 Boehringer Ingelheim Investigational Site
  • Peru
      • Cercado, Peru
        • 1200.44.19005 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1200.44.19001 Boehringer Ingelheim Investigational Site
      • Lima, Peru
        • 1200.44.19004 Boehringer Ingelheim Investigational Site
      • San Isidro, Peru
        • 1200.44.19003 Boehringer Ingelheim Investigational Site
  • United States
    • Texas
      • Houston, Texas, United States
        • 1200.44.01001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
Drug: BIBW 2992
BIBW 2992 high dose once daily (allowed dose reduction to medium or low once daily in case of AE)
Active Comparator: Lapatinib
Lapatinib tablets 1500 mg daily.
Drug: lapatinib
lapatinib tablets 1500 mg daily
Active Comparator: Trastuzumab
Trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly.
Drug: trastuzumab
trastuzumab 4mg/kg i.v. week 1, followed by 2mg/kg i.v. weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Tumour assessments were performed at screening, day 22 and day 43.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Tumour assessments were performed at screening, day 22 and day 43.
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 weeks or 6 weeks
Plasma Concentration of Afatinib
Time Frame: Day 7
Individual drug plasma concentrations of afatinib after multiple oral administrations at day 7
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.
Screening, day 22, day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on BIBW 2992

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe