At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 4,590 enrolled
Drug / intervention
immunohistochemistry staining method +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
In Brief
A Phase 3 clinical trial evaluating immunohistochemistry staining method, lymphangiography, and 3 other interventions for Breast Cancer. Completed, enrolled 4,590 participants across 116 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Ireland, United States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 1999
First PostedJan 2003
Primary CompletionAug 2006
Study CompletionJul 2011
TodayJul 2026
First PostedJan 27, 2003
Enrollment StartApr 1, 1999
Primary CompletionAug 1, 2006
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 23.4 years ago
Interventions
immunohistochemistry staining methodother
lymphangiographyprocedure
sentinel lymph node biopsyprocedure
therapeutic conventional surgeryprocedure
whole breast irradiationradiation