RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.
OBJECTIVES: * Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer. * Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients. * Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H\&E) staining. * Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H\&E so that these women can be considered as candidates for ACOSOG-Z0011.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4,590
Overall survival
Time frame: Up to 10 years
Disease-free survival
Time frame: Up to 10 years
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Time frame: Up to 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Providence Hospital - Mobile AL
Mobile, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Summit Medical Center
Oakland, California, United States
St. Joseph Hospital - Orange
Orange, California, United States
...and 106 more locations