Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088829
Status:
TERMINATED
Last Update Posted:
2018-07-11
First Post:
2004-08-04
Brief Title:
Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Pilot Study to Establish a Standardized Protocol for Gene Microarray Analysis in Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer Identifying Factors Predictive of a Response to Paclitaxel
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Analyzing genes for changes before and after chemotherapy may help doctors predict a patients response to treatment and help plan the most effective treatment
PURPOSE This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer
PURPOSE This clinical trial is studying how well genetic testing works in predicting response to paclitaxel in women who have unresected breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status
Determine a standard protocol template for gene microarray analysis in terms of the timing and method of collecting tissue samples before and after administration of neoadjuvant paclitaxel in these patients
Determine the safety and efficacy of tissue sampling in these patients
Secondary
Identify genes or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients
Identify genes or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients
Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug
Develop preliminarily a statistical model utilizing individual genes andor gene clusters that can best predict response to paclitaxel in these patients
OUTLINE This is a pilot multicenter study
Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel upon completion of course 1 and either upon completion of the last course in patients with clinical or radiographic evidence of residual disease or during definitive breast surgery Biopsy samples are analyzed for gene expression by gene microarray analysis
Patients are followed for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
Primary
Determine the feasibility of accruing women with unresected infiltrating carcinoma of the breast to a clinical trial involving serial breast biopsies and administration of neoadjuvant paclitaxel before formal assessment of axillary lymph node status
Determine a standard protocol template for gene microarray analysis in terms of the timing and method of collecting tissue samples before and after administration of neoadjuvant paclitaxel in these patients
Determine the safety and efficacy of tissue sampling in these patients
Secondary
Identify genes or gene clusters that exhibit significant differences between responding and non-responding tumors before treatment with neoadjuvant paclitaxel in these patients
Identify genes or gene clusters that exhibit changes in gene expression before and after the administration of neoadjuvant paclitaxel in these patients
Compare significant differences in gene expression between responding and non-responding tumors in patients treated with this drug
Develop preliminarily a statistical model utilizing individual genes andor gene clusters that can best predict response to paclitaxel in these patients
OUTLINE This is a pilot multicenter study
Patients undergo core needle breast biopsy within 14 days before starting neoadjuvant paclitaxel treatment Patients receive neoadjuvant paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo core needle breast biopsy 48 hours after the first administration of paclitaxel upon completion of course 1 and either upon completion of the last course in patients with clinical or radiographic evidence of residual disease or during definitive breast surgery Biopsy samples are analyzed for gene expression by gene microarray analysis
Patients are followed for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50CA058185 | NIH | None | None |
| P30CA051008 | NIH | None | None |
| GUMC-00310 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |