Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Inflammatory Breast Carcinoma
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity. SECONDARY OBJECTIVES: I. Compare...

PRIMARY OBJECTIVES: I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity. SECONDARY OBJECTIVES: I. Compare the medical outcomes for patients receiving LVB surgery with those receiving standard surgery without the intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND. GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND. After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.

Tracking Information

NCT #
NCT03941756
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Schaverien M.D. Anderson Cancer Center