- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898573
Lapatinib Resistance in Patients With Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Genetic: gene expression analysis
- Other: laboratory biomarker analysis
- Genetic: mutation analysis
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: immunohistochemistry staining method
- Genetic: polymerase chain reaction
- Drug: lapatinib ditosylate
- Genetic: fluorescence in situ hybridization
- Other: cell sorting
Detailed Description
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.
Study Type
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44024
- Geauga Regional Hospital
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Cleveland, Ohio, United States, 44060
- Lake/University Ireland Cancer Center
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Cleveland, Ohio, United States, 44121
- University Suburban Health Center
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Cleveland, Ohio, United States, 44122
- UHHS Chagrin Highlands Medical Center
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Cleveland, Ohio, United States, 44130
- Southwest General Health Center
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Cleveland, Ohio, United States, 44145
- UHHS Westlake Medical Center
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Cleveland, Ohio, United States, 44708
- Mercy Cancer Center at Mercy Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Balazs Halmos, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE15107 (Other Identifier: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH Grant/Contract)
- CASE-15107-CC488
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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