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NCT00003830 · ClinicalTrials.gov registry record · Phase 3
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,611
- Enrollment target
- 20
- Study locations
NCT00003830: Completed Phase 3 study of Breast Cancer, sponsored by NSABP Foundation.
NCT00003830 is a Phase 3 study of Breast Cancer that has completed, run by NSABP Foundation. The registered enrollment target is 5,611 participants, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003830, a Phase 3 study of Breast Cancer, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,611 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
Primary Outcome
Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
Conditions Studied
Interventions
- PROCEDURE conventional surgery
- PROCEDURE Sentinel node resection followed by node examination
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
- Sutter Breast Cancer Group - Sacramento
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego - San Diego
- Stanford Cancer Center at Stanford University Medical Center - Stanford
Florida
- Halifax Medical Center - Daytona Beach
- Baptist Regional Cancer Institute - Jacksonville - Jacksonville
- University of Miami Sylvester Cancer Center - Miami
- CCOP - Mount Sinai Medical Center - Miami Beach
- Sarasota Memorial Hospital - Sarasota
Illinois
- MBCCOP-Cook County Hospital - Chicago
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center - Chicago
- CCOP - Illinois Oncology Research Association - Peoria
Indiana
- Methodist Cancer Center at Methodist Hospital - Indianapolis
- CCOP - Northern Indiana CR Consortium - South Bend
Alabama
- MBCCOP - Gulf Coast - Mobile
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- MBCCOP - Howard University Cancer Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,611 participants |
| Start Date | 1999-05 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00003830 record still lists
NCT00003830 is an interventional study that assigns participants to a tested intervention. Its 5,611 participants enrollment target places it among the larger protocols in the corpus, above the 2,799-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which conventional surgery is the first listed.
NCT00003830 names 20 study sites across 9 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00003830 about?
NCT00003830 is a clinical study titled "Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer". RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast c...
What is the current status of trial NCT00003830?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,611 participants. The study started on 1999-05. Estimated completion is 2014-02.
What conditions does trial NCT00003830 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00003830?
The interventions under investigation include: conventional surgery (PROCEDURE), Sentinel node resection followed by node examination (PROCEDURE).
Who is sponsoring clinical trial NCT00003830?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00003830 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00003830's enrollment target sits among peer trials
5,611 26th of 1224 higher than 1,199 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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