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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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
microarray analysis
immunohistochemistry staining method
conventional surgery
lymphangiography
radionuclide imaging
sentinel lymph node biopsy
technetium Tc 99m sulfur colloid
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Stage II, III, or IV infiltrating disease Unilateral or bilateral AND unifocal or multifocal disease Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal therapy, and/or biologic therapy) AND had any of the following responses: Clinical complete response, partial response, no change, or disease progression Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Hemoglobin > 7.0 g/dL Platelet count > 50,000/mm^3 WBC > 2,000/mm^3 Hepatic PT and PTT < 1.5 times normal Renal Not specified Other Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy See Disease Characteristics Radiotherapy No prior definitive breast radiotherapy to the target breast Surgery No prior axillary surgery on the side of the sentinel lymph node Other More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission tomography scan, or MUGA scan)

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
March 7, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00080860
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
lymphangiography
Intervention Type
Procedure
Intervention Name(s)
radionuclide imaging
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Intervention Type
Radiation
Intervention Name(s)
technetium Tc 99m sulfur colloid

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the breast Stage II, III, or IV infiltrating disease Unilateral or bilateral AND unifocal or multifocal disease Received at least 1 course of prior preoperative therapy (chemotherapy, hormonal therapy, and/or biologic therapy) AND had any of the following responses: Clinical complete response, partial response, no change, or disease progression Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age Over 18 Sex Female Menopausal status Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Hemoglobin > 7.0 g/dL Platelet count > 50,000/mm^3 WBC > 2,000/mm^3 Hepatic PT and PTT < 1.5 times normal Renal Not specified Other Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy See Disease Characteristics Radiotherapy No prior definitive breast radiotherapy to the target breast Surgery No prior axillary surgery on the side of the sentinel lymph node Other More than 3 days since prior radionuclide scan (e.g., bone scan, positron-emission tomography scan, or MUGA scan)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David N. Danforth, MD, MS
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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