NCT00898573

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

9 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

First QC Date

May 9, 2009

Last Update Submit

October 1, 2015

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (3)

  • Secondary ErbB2 mutations

  • ErbB2 copy number changes and expression levels

  • Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance

Interventions

lapatinib ditosylateDRUG
fluorescence in situ hybridizationGENETIC
gene expression analysisGENETIC
mutation analysisGENETIC
polymerase chain reactionGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
cell sortingOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

DISEASE CHARACTERISTICS: * Pathologically confirmed invasive breast cancer * ErbB2-positive disease * Has received or is currently receiving lapatinib ditosylate * Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response) * Must have tumor tissue samples available for research studies * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Not pregnant\* * Coagulation profile normal\* * Platelet count \> 100,000/mm³\* NOTE: \*For patients requiring a post-treatment biopsy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Concurrent chemotherapy or trastuzumab (Herceptin®) allowed * No concurrent anticoagulants, including warfarin or low-molecular weight heparin\* * No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents\* NOTE: \*For patients requiring a post-treatment biopsy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Geauga Regional Hospital

Cleveland, Ohio, 44024, United States

Location

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44121, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Mercy Cancer Center at Mercy Medical Center

Cleveland, Ohio, 44708, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Previously collected tumor tissue samples are obtained for genetic analysis studies. Patients also undergo blood sample collection for extraction of DNA.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LapatinibIn Situ Hybridization, FluorescenceGene Expression ProfilingPolymerase Chain ReactionReverse Transcriptase Polymerase Chain ReactionCell SeparationImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationNucleic Acid Amplification TechniquesHistocytochemistryImmunologic Techniques

Study Officials

  • Thomas Budd, MD

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Balazs Halmos, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 1, 2008

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

US(9)