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Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
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: * 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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 1, 2008
Last Updated
October 2, 2015
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
immunohistochemistry staining method
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
Case Comprehensive Cancer Center
Collaborators
NCT04550494
NCT05245812
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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