Clinical Trials

Inclusion Criteria:

• Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by:
  • negative clinical exam; and/or
  • negative axillary US; and/or
  • negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
• Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
• Patients will be staged according to the TNM staging system. 
• Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.
  •  Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration. 
• No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration). 
• No bilateral invasive breast cancer. 
• No matted nodes.
• No history of lymphedema of either arm.
• No known allergies blue dyes, including make-up containing blue dye.
• In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English. 
• Female : Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. 
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 
• Creatinine: ≤ 1.5 x upper limit of normal (ULN).