Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080860
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2004-04-07
Brief Title:
Sentinel Lymph Node Biopsy and Primary Tumor Gene Expression Profiling in Finding Axillary Lymph Node Metastases in Women Who Have Received Neoadjuvant Therapy for Stage II Stage III or Stage IV Breast Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Efficacy Of Sentinel Lymph Node Biopsy And Primary Tumor Gene Expression Profiling To Detect Axillary Lymph Node Metastases After Neoadjuvant Chemotherapy For Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
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:
RATIONALE Sentinel lymph node biopsy and gene expression profiling of the primary breast tumor may help determine if tumor cells have spread to the axillary lymph nodes and help doctors plan more effective surgery for breast cancer
PURPOSE This clinical trial is studying how well sentinel lymph node biopsy and primary tumor gene expression profiling work in finding lymph node metastases in women who have received neoadjuvant therapy for stage II stage III or stage IV breast cancer
PURPOSE This clinical trial is studying how well sentinel lymph node biopsy and primary tumor gene expression profiling work in finding lymph node metastases in women who have received neoadjuvant therapy for stage II stage III or stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node status after neoadjuvant therapy in women with stage II III or IV breast cancer
Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients
OUTLINE This is a pilot study
After neoadjuvant chemotherapy patients undergo sentinel lymph node SLN mapping comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify the SLN Within 1-2 hours after injection patients undergo SLN biopsy followed immediately by definitive local surgery comprising modified radical mastectomy or breast segmentectomy with axillary lymph node dissection SLN and axillary lymph nodes are examined by hematoxylin and eosin H E staining for the presence or absence of metastases If the lymph nodes are negative for tumor by H E the lymph nodes are further analyzed by immunohistochemistry The primary tumor is analyzed by microarray analysis for gene expression profile determinations
Patients are followed at 2-3 weeks after surgery
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2-3 years
Determine the efficacy of sentinel lymph node mapping for assessing axillary lymph node status after neoadjuvant therapy in women with stage II III or IV breast cancer
Correlate gene expression profiling of the primary breast cancer with axillary and sentinel lymph node status in these patients
OUTLINE This is a pilot study
After neoadjuvant chemotherapy patients undergo sentinel lymph node SLN mapping comprising technetium Tc 99m sulfur colloid injected into the subareolar area to identify the SLN Within 1-2 hours after injection patients undergo SLN biopsy followed immediately by definitive local surgery comprising modified radical mastectomy or breast segmentectomy with axillary lymph node dissection SLN and axillary lymph nodes are examined by hematoxylin and eosin H E staining for the presence or absence of metastases If the lymph nodes are negative for tumor by H E the lymph nodes are further analyzed by immunohistochemistry The primary tumor is analyzed by microarray analysis for gene expression profile determinations
Patients are followed at 2-3 weeks after surgery
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2-3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000356050 | None | None | None |
| 04-C-0114 | None | None | None |