Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212069
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2005-09-13
Brief Title:
Serum Proteomics to Predict Gemcitabine Sensitivity in Breast Cancer
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Serum Protein Profiling as a Predictor of Gemcitabine Sensitivity in Breast Cancer With Prior Exposure to Anthracyclines and Taxanes
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tumors are heterogeneous with varying response to chemotherapeutic agents We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant We further hypothesize that since tumor is continuously perfused by serum serum protein profile can be used as a surrogate marker of tumor protein profile The primary objective of this study is to identify a serum protein profile that predicts gemcitabinecarboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics
Detailed Description:
Metastatic breast cancer patients previously treated with anthracyclines and taxanes will be treated with gemcitabine and carboplatin every 3 weeks Serial plasma samples will be collected for proteomics profiling with SELDI-MS that will be correlated with tumor response to identify biomarkers that may predict for chemotherapy sensitivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None