Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2008-07-31
Brief Summary
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PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.
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Detailed Description
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* To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
* To investigate ErbB2 copy number changes and expression levels.
* To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
OUTLINE: Previously collected tumor tissue samples\* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
NOTE: \*Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Interventions
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lapatinib ditosylate
fluorescence in situ hybridization
gene expression analysis
mutation analysis
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
cell sorting
immunohistochemistry staining method
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Thomas Budd, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Balazs Halmos, MD
Role: PRINCIPAL_INVESTIGATOR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Geauga Regional Hospital
Cleveland, Ohio, United States
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University Suburban Health Center
Cleveland, Ohio, United States
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States
Southwest General Health Center
Cleveland, Ohio, United States
UHHS Westlake Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE15107
Identifier Type: OTHER
Identifier Source: secondary_id
CASE-15107-CC488
Identifier Type: -
Identifier Source: secondary_id
CASE15107
Identifier Type: -
Identifier Source: org_study_id
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