NCT00826267

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 17, 2013

Completed
Last Updated

December 31, 2013

Status Verified

August 1, 2013

Enrollment Period

2.6 years

First QC Date

January 20, 2009

Results QC Date

August 8, 2013

Last Update Submit

December 5, 2013

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Objective Response (OR)

    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 Outcomes (4)

  • Number of Participants Who Achieved Clinical Benefit (CB)

    Tumour assessments were performed at screening, day 22 and day 43.

  • Change From Baseline in the Diameter of the Primary Target Lesion.

    3 weeks or 6 weeks

  • Plasma Concentration of Afatinib

    Day 7

  • Changes in Biomarker in Tumour Biopsies

    Screening, day 22, day 43

Study Arms (3)

BIBW 2992

EXPERIMENTAL

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

Drug: BIBW 2992

Lapatinib

ACTIVE COMPARATOR

Lapatinib tablets 1500 mg daily.

Drug: lapatinib

Trastuzumab

ACTIVE COMPARATOR

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

Drug: trastuzumab

Interventions

lapatinibDRUG

lapatinib tablets 1500 mg daily

Lapatinib
BIBW 2992DRUG

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

BIBW 2992
trastuzumabDRUG

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

Trastuzumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

1200.44.01001 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1200.44.12008 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1200.44.12011 Boehringer Ingelheim Investigational Site

Cachoeiro de Itapemirim, Brazil

Location

1200.44.12012 Boehringer Ingelheim Investigational Site

Campo Grande, Brazil

Location

1200.44.12009 Boehringer Ingelheim Investigational Site

Caxias do Sul, Brazil

Location

1200.44.12010 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

1200.44.12005 Boehringer Ingelheim Investigational Site

Ijuí, Brazil

Location

1200.44.12007 Boehringer Ingelheim Investigational Site

Natal, Brazil

Location

1200.44.12004 Boehringer Ingelheim Investigational Site

Novo Hamburgo, Brazil

Location

1200.44.12001 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1200.44.12013 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1200.44.14002 Boehringer Ingelheim Investigational Site

Bogotá, Colombia

Location

1200.44.14001 Boehringer Ingelheim Investigational Site

Cali, Colombia

Location

1200.44.19005 Boehringer Ingelheim Investigational Site

Cercado, Peru

Location

1200.44.19001 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1200.44.19004 Boehringer Ingelheim Investigational Site

Lima, Peru

Location

1200.44.19003 Boehringer Ingelheim Investigational Site

San Isidro, Peru

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LapatinibAfatinibTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAmidesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Limitations and Caveats

Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 pat. Small number of subjects lead to some shortcomings in analyses.

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Last Updated

December 31, 2013

Results First Posted

October 17, 2013

Record last verified: 2013-08

Locations

US(1)BR(10)CO(2)PE(4)