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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE15107 | Other Identifier | Case Comprehensive Cancer Center | |
| CASE-15107-CC488 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lapatinib ditosylate | Drug | |||
| fluorescence in situ hybridization | Genetic | |||
| gene expression analysis | Genetic | |||
| mutation analysis | Genetic | |||
| polymerase chain reaction | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| cell sorting | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Pathologically confirmed invasive breast cancer
Has received or is currently receiving lapatinib ditosylate
Must have tumor tissue samples available for research studies
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geauga Regional Hospital | Cleveland | Ohio | 44024 | United States | ||
| Lake/University Ireland Cancer Center |
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Previously collected tumor tissue samples are obtained for genetic analysis studies. Patients also undergo blood sample collection for extraction of DNA.
| immunohistochemistry staining method | Other |
| laboratory biomarker analysis | Other |
| Cleveland |
| Ohio |
| 44060 |
| United States |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| University Suburban Health Center | Cleveland | Ohio | 44121 | United States |
| UHHS Chagrin Highlands Medical Center | Cleveland | Ohio | 44122 | United States |
| Southwest General Health Center | Cleveland | Ohio | 44130 | United States |
| UHHS Westlake Medical Center | Cleveland | Ohio | 44145 | United States |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| Mercy Cancer Center at Mercy Medical Center | Cleveland | Ohio | 44708 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077341 | Lapatinib |
| D017404 | In Situ Hybridization, Fluorescence |
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D002469 | Cell Separation |
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D017403 | In Situ Hybridization |
| D013194 | Staining and Labeling |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D020732 | Cytogenetic Analysis |
| D005821 | Genetic Techniques |
| D009693 | Nucleic Acid Hybridization |
| D021141 | Nucleic Acid Amplification Techniques |
| D006651 | Histocytochemistry |
| D007158 | Immunologic Techniques |
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