NCT00898573

Lapatinib Resistance in Patients With Breast Cancer

Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• First posted: 2009-05-12
• Last updated: 2015-10-02

Locations

9 sites across 1 country: United States