Lapatinib Resistance in Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00898573|
Recruitment Status : Withdrawn
First Posted : May 12, 2009
Last Update Posted : October 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: lapatinib ditosylate Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: cell sorting Other: immunohistochemistry staining method Other: laboratory biomarker analysis||Phase 1|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers|
|Study Start Date :||July 2008|
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898573
|United States, Ohio|
|Geauga Regional Hospital|
|Cleveland, Ohio, United States, 44024|
|Lake/University Ireland Cancer Center|
|Cleveland, Ohio, United States, 44060|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|University Suburban Health Center|
|Cleveland, Ohio, United States, 44121|
|UHHS Chagrin Highlands Medical Center|
|Cleveland, Ohio, United States, 44122|
|Southwest General Health Center|
|Cleveland, Ohio, United States, 44130|
|UHHS Westlake Medical Center|
|Cleveland, Ohio, United States, 44145|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Mercy Cancer Center at Mercy Medical Center|
|Cleveland, Ohio, United States, 44708|
|Principal Investigator:||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|