Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212082
Status:
COMPLETED
Last Update Posted:
2008-06-12
First Post:
2005-09-13
Brief Title:
Gene Expression Profiles in Predicting Chemotherapy Response in Breast Cancer
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Gene Expression Profiles of Breast Cancer Treated With Sequential Adriamycin and Docetaxel in Relation to Tumor Responses
Status:
COMPLETED
Status Verified Date:
2008-06
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:
We hypothesize that changes in tumor gene expression profiles vary in response to different sequences and types of chemotherapy and that gene expression changes will correlate with tumor response We are also looking to correlate drug pharmacokinetics and treatment toxicity with genotype of drug metabolizing enzymes and tranportersPatients with metastatic breast cancer and who have measurable primary breast tumor will be randomized to one of two alternating sequences of adriamycin and docetaxel Serial tumor biopsies and plasma samples will be obtained for gene expression and proteomic studies to identify biomarkers that will predict for chemotherapy response
Detailed Description:
Significant inter-individual variation exists in tumor response and chemotherapy toxicity because of unique tumor and patient factors Individual drugs with distinct mechanisms of action may induce specific genomic and proteomic changes that may be used as predictor for response We plan to study serial genomic and proteomic profiles in primary breast tumor treated with one of two sequences of alternating adriamycin A and docetaxel T ATATAT or TATATA at 75mgm2 3 weekly for each drug Pharmacokinetic analysis of both drugs will be performed amplified tumor RNA will be hybridized on Affymetrix HG-U1332 array tumor proteins will be fractionated and profiled with ProteinChip Array SELDI MS Ciphergen Tumor gene expression and proteomic changes will be correlated with treatment response to identify biomarkers that may predict 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