Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axill… (NCT03927027) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
United States534 participantsStarted 2019-07-29
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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, partici…