NCT00003854

Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,590 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	immunohistochemistry staining method
PROCEDURE	lymphangiography
PROCEDURE	sentinel lymph node biopsy
PROCEDURE	therapeutic conventional surgery
RADIATION	whole breast irradiation

Timeline

• Start date: 1999-04-01
• Primary completion: 2006-08-01
• Completion: 2011-07-01
• First posted: 2003-01-27
• Last updated: 2016-07-13

Locations

116 sites across 3 countries: United States, Australia, Ireland