Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection
Purpose
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.
Conditions
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Criteria
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).
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Group I (ALND) |
Patients receive isosulfan blue SC and undergo ALND. |
|
|
Experimental Group II (ARM, ALND) |
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03927027
- Status
- Active, not recruiting
- Sponsor
- Alliance for Clinical Trials in Oncology
Detailed Description
PRIMARY OBJECTIVES: I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping [ARM]) versus Group II (ARM). SECONDARY OBJECTIVES: I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics. III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM. EXPLORATORY OBJECTIVES: I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND). GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. After completion of study, patients are followed up for 3 years.