Status:
TERMINATED
Axillary Lymph Node Preservation Surgery in Reducing Lymphedema in Patients With Breast Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE1
PHASE2
Brief Summary
This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast ...
Detailed Description
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at r...
Eligibility Criteria
Inclusion
- \- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
Exclusion
- Prior lymphedema in either arm
- Prior history of axillary surgery (except for sentinel node biopsies)
- Prior history of chest/axillary radiation
- Need for bilateral axillary node dissection surgery
- Prior neurologic deficits (either motor or sensory) in ipsilateral arm
- Known allergy to vital blue dyes
- No prior diagnosis of inflammatory breast cancer
- Cannot be pregnant or planning to continue breast-feeding immediately after surgery
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00932035
Start Date
June 1 2009
End Date
May 1 2014
Last Update
June 7 2017
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of California, Davis Medical Center
Sacramento, California, United States, 95817
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-1350