Spots Global Cancer Trial Database for Lapatinib Resistance in Patients With Breast Cancer
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Trial Identification
Brief Title: Lapatinib Resistance in Patients With Breast Cancer
Official Title: Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
Study ID: NCT00898573
Conditions
Study Description
Brief Summary: 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.
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Thomas Budd, MD
Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Balazs Halmos, MD
Affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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