Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233974
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2005-10-05
Brief Title:
Molecular Marker Profiling of Axillary Lymph Nodes in Predicting Response in Patients With Locally Advanced or Metastatic Breast Cancer Who Are Undergoing Chemotherapy Followed By Surgery
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Axillary Lymph Nodes and PET Positron Emission Tomography Probe-Guided Surgical Resection in Locally Advanced Breast Cancer Patients Molecular Marker Profile and Response to Neoadjuvant Chemotherapy
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 Comparing results of diagnostic procedures such as molecular marker profiling done before and after chemotherapy may help doctors predict a patients response to treatment and help plan the best treatment
PURPOSE This phase II trial is studying how well molecular marker profiling of axillary lymph nodes works in predicting response in patients with locally advanced or metastatic breast cancer who are undergoing chemotherapy followed by surgery
PURPOSE This phase II trial is studying how well molecular marker profiling of axillary lymph nodes works in predicting response in patients with locally advanced or metastatic breast cancer who are undergoing chemotherapy followed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine whether molecular markers in pretreatment axillary lymph node metastases can predict pathologic response to neoadjuvant chemotherapy in patients with locally advanced or early metastatic breast cancer
Secondary
Compare molecular markers in axillary lymph node metastases with those in the primary breast tumor obtained in protocol UNC-LCCC-9819 in patients treated with neoadjuvant chemotherapy
Determine changes in molecular markers in lymph nodes before and after treatment with neoadjuvant chemotherapy in these patients
Determine the proportion of clinical axillary lymph node-negative patients who have histopathologically node-positive disease identified by sentinel lymph node biopsy
Determine the rate of breast preservation in patients with large breast cancers treated with neoadjuvant chemotherapy followed by fludeoxyglucose F 18 positron emission tomography probe-guided surgical resection
OUTLINE Patients undergo open surgical biopsy of axillary lymph nodes OR intraoperative lymphatic mapping and sentinel lymphadenectomy for clinically node-positive or clinically node-negative disease respectively before and after neoadjuvant chemotherapy The axillary lymph node tissue is examined for molecular and protein markers by immunohistochemistry and fluorescence in situ hybridization Patients also undergo fludeoxyglucose F 18 positron emission tomography FDG-PET once before and then once after neoadjuvant chemotherapy Beginning 1 hour before surgery patients receive an injection of FDG and then undergo conventional segmental mastectomy lumpectomy with or without needle localization followed by FDG-PET probe-guided surgical resection of any remaining FDG-avid tumor tissue
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 5 years
Primary
Determine whether molecular markers in pretreatment axillary lymph node metastases can predict pathologic response to neoadjuvant chemotherapy in patients with locally advanced or early metastatic breast cancer
Secondary
Compare molecular markers in axillary lymph node metastases with those in the primary breast tumor obtained in protocol UNC-LCCC-9819 in patients treated with neoadjuvant chemotherapy
Determine changes in molecular markers in lymph nodes before and after treatment with neoadjuvant chemotherapy in these patients
Determine the proportion of clinical axillary lymph node-negative patients who have histopathologically node-positive disease identified by sentinel lymph node biopsy
Determine the rate of breast preservation in patients with large breast cancers treated with neoadjuvant chemotherapy followed by fludeoxyglucose F 18 positron emission tomography probe-guided surgical resection
OUTLINE Patients undergo open surgical biopsy of axillary lymph nodes OR intraoperative lymphatic mapping and sentinel lymphadenectomy for clinically node-positive or clinically node-negative disease respectively before and after neoadjuvant chemotherapy The axillary lymph node tissue is examined for molecular and protein markers by immunohistochemistry and fluorescence in situ hybridization Patients also undergo fludeoxyglucose F 18 positron emission tomography FDG-PET once before and then once after neoadjuvant chemotherapy Beginning 1 hour before surgery patients receive an injection of FDG and then undergo conventional segmental mastectomy lumpectomy with or without needle localization followed by FDG-PET probe-guided surgical resection of any remaining FDG-avid tumor tissue
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 5 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 |
|---|---|---|---|
| CDR0000439444 | OTHER | PDQ number | None |