Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema
in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse
mapping may help to preserve the lymph node drainage system around the breast so as to
prevent lymphedema after surgery.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Breast Cancer
Enrollment Eligibility
Inclusion Criteria:
- Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally
meet one of the following conditions:
- 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 i) negative clinical exam and/or
ii) negative axillary US and/or iii) 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.
o 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).