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

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, April 2009

First Received: January 20, 2009 Last Updated: April 23, 2009 History of Changes

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00826267

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: BIBW 2992 Drug: Lapatinib Drug: Trastuzumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab Lapatinib Lapatinib Ditosylate BIBW 2992

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study
Official Title:	Randomised Phase II Study of Neoadjuvant BIBW 2992 Versus Herceptin Versus Lapatinib in Her2 Positive Breast Cancer Patients

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Objective response rate [ Time Frame: 6 weeks ]

Secondary Outcome Measures:

Clinical benefit rate, PK, changes in biomarker in tumor biopsies, safety [ Time Frame: 6 weeks ]

Estimated Enrollment:	120
Study Start Date:	January 2009
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Boehringer Ingelheim Study Coordinator

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Locations

United States, Texas
1200.44.01001 Boehringer Ingelheim Investigational Site	Recruiting
Houston, Texas, United States
Mexico
1200.44.16001 Boehringer Ingelheim Investigational Site	Not yet recruiting
Acapulco, Mexico
1200.44.16002 Boehringer Ingelheim Investigational Site	Not yet recruiting
Distrito Federal, Mexico
1200.44.16003 Boehringer Ingelheim Investigational Site	Not yet recruiting
Monterrey, Mexico

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1200.44
Study First Received:	January 20, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00826267 History of Changes
Health Authority:	Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica; Brazil: National Committee of Ethics in Research; Chile: Instituto de Salud Publica de Chile; Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Costa Rica: Ministry of Health Costa Rica; Mexico: Federal Commission for Protection Against Health Risks; Panama: Ministry of Health; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms

Lapatinib
Protein Kinase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Lapatinib
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009