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

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: lapatinib Drug: BIBW 2992 Drug: trastuzumab	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Objective response rate [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical benefit rate: CR, PR, SD as determined by RECIST criteria. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The sum of the longest diameters of the target lesion. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics (PK). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Changes in biomarker in tumor biopsies. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Safety of BIBW 2992 as indicated by intensity and incidence of adverse events, graded according to US NCI CTCAE version 3.0, lab evaluation, patient performance and cardiac left ventricular function. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Analysis of sub-groups and potential prognostic factors including exploration of different classifications of patients according to: IHC of HER2/ER/PgR status and HER2 (FISH if HER2 IHC 2+). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	29
Study Start Date:	January 2009
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826267

Locations

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

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00826267 History of Changes
Other Study ID Numbers:	1200.44
Study First Received:	January 20, 2009
Last Updated:	February 8, 2012
Health Authority:	Brazil: National Health Surveillance Agency Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos Peru: General Directorate of Pharmaceuticals, Devices, and Drugs United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
Lapatinib

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013