Lapatinib Resistance in Patients With Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00898573
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Geauga Regional Hospital
🇺🇸Cleveland, Ohio, United States
Lake/University Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
University Suburban Health Center
🇺🇸Cleveland, Ohio, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Southwest General Health Center
🇺🇸Cleveland, Ohio, United States
UHHS Chagrin Highlands Medical 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