Breast Cancer Clinical Trial
Official title:
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.
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Observational Model: Case-Only, Time Perspective: Cross-Sectional
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