The long term objectives of this proposal are to develop and refine methods of breast cancer staging in patients that are substantially less morbid than current methods, yet still provide the same diagnostic and therapeutic benefits. For the past six years, in partnership with the National Surgical Adjuvant Breast and Bowel cooperative group (NSABP), we have been conducting a large, multi-center, randomized, phase III prospective trial to compare sentinel node resection to conventional axillary dissection in clinically node-negative breast cancer patients. The University of Vermont (UVM) and NSABP share responsibility for overall trial design, protocol development, and statistical analysis. UVM has primary responsibility for 1) training and quality control of all aspects of sentinel node surgery and the pathological evaluation of sentinel nodes and 2) performance and statistical analysis of an ancillary pathology study for detection and determination of the prognostic significance of """"""""occult"""""""" node metastases. The scope of this competing continuation proposal includes 1) continuation of the existing sentinel node trial and 2) an additional ancillary study evaluating highly promising prognostic methods. The additional ancillary study will be structured on the same successful partnership of UVM and NSABP and will include evaluation of bone marrow micrometastases.
The specific aims are #1 and #2) determine whether sentinel node resection alone compared to axillary dissection plus sentinel node resection results in equivalent long-term control of regional disease (Aim 1) and disease free and overall survival (Aim 2), aim #3 and #4 determine the magnitude of morbidity reduction (Aim 3) and improved quality of life (Aim 4) of sentinel node resection versus axillary resection, aim #5 determine whether immunohistochemical (IHC) analysis of hematoxylin and eosin (H&E) negative sentinel nodes identifies patients at risk for decreased overall and disease free survival, aim #6 establish a standardized method of sentinel node surgery in a large number of centers, and aim #7 determine the comparative effectiveness of bone marrow micrometastases for predicting the survival of breast cancer patients. ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA074137-09
Application #
7244453
Study Section
Clinical Oncology Study Section (CONC)
Program Officer
Xie, Heng
Project Start
1998-07-01
Project End
2009-06-30
Budget Start
2007-05-01
Budget End
2009-06-30
Support Year
9
Fiscal Year
2007
Total Cost
$850,024
Indirect Cost
Name
University of Vermont & St Agric College
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405
Pesek, Sarah; Ashikaga, Taka; Krag, Lars Erik et al. (2012) The false-negative rate of sentinel node biopsy in patients with breast cancer: a meta-analysis. World J Surg 36:2239-51
Weaver, Donald L; Ashikaga, Takamaru; Krag, David N et al. (2011) Effect of occult metastases on survival in node-negative breast cancer. N Engl J Med 364:412-21
Land, Stephanie R; Kopec, Jacek A; Julian, Thomas B et al. (2010) Patient-reported outcomes in sentinel node-negative adjuvant breast cancer patients receiving sentinel-node biopsy or axillary dissection: National Surgical Adjuvant Breast and Bowel Project phase III protocol B-32. J Clin Oncol 28:3929-36
Krag, David N; Anderson, Stewart J; Julian, Thomas B et al. (2010) Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol 11:927-33
Krag, David N (2010) Current status of axillary lymph node dissection and sentinel node biopsy in breast cancer. Clin Adv Hematol Oncol 8:471-3
Ashikaga, Takamaru; Krag, David N; Land, Stephanie R et al. (2010) Morbidity results from the NSABP B-32 trial comparing sentinel lymph node dissection versus axillary dissection. J Surg Oncol 102:111-8
Weaver, Donald L (2010) Pathology evaluation of sentinel lymph nodes in breast cancer: protocol recommendations and rationale. Mod Pathol 23 Suppl 2:S26-32
Krag, David N; Kusminsky, Roberto; Manna, Edward et al. (2009) Cytokeratin-positive cells in the bone marrow of breast cancer patients and noncancer donors. Appl Immunohistochem Mol Morphol 17:403-8
Krag, David N; Ashikaga, Takamaru; Harlow, Seth P et al. (2009) Surgeon training, protocol compliance, and technical outcomes from breast cancer sentinel lymph node randomized trial. J Natl Cancer Inst 101:1356-62
Krag, David N; Kusminsky, Roberto; Manna, Edward et al. (2005) The detection of isolated tumor cells in bone marrow comparing bright-field immunocytochemistry and multicolor immunofluorescence. Ann Surg Oncol 12:753-60

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