Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Locations
- 9
- Primary Endpoint
- ErbB2 copy number changes and expression levels
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
ErbB2 copy number changes and expression levels
Secondary ErbB2 mutations
Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance