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 Genders
- 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
Little Rock, Arkansas 72205
Site Public Contact
501-686-8274
Martinez, California 94553-3156
Site Public Contact
925-957-5400
Oakland, California 94609
Site Public Contact
510-204-1414
Fort Lauderdale, Florida 33308
Site Public Contact
954-267-7750
Gainesville, Florida 32610
Jacksonville, Florida 32224-9980
Site Public Contact
855-776-0015
Orlando, Florida 32806
Fayetteville, Georgia 30214
Oak Lawn, Illinois 60453-2699
Site Public Contact
800-323-8622
Goshen, Indiana 46526
Kansas City, Kansas 66160
Overland Park, Kansas 66211
Westwood, Kansas 66205
Louisville, Kentucky 40202
Site Public Contact
502-562-3429
Bay City, Michigan 48706
Clinton Township, Michigan 48038
Detroit, Michigan 48201
Detroit, Michigan 48202
Farmington Hills, Michigan 48334
West Bloomfield, Michigan 48322
Somerville, New Jersey 08876
New York, New York 10032
Rochester, New York 14623
Rochester, New York 14642
Site Public Contact
585-275-5830
Chapel Hill, North Carolina 27599
Winston-Salem, North Carolina 27157
Site Public Contact
336-713-6771
Akron, Ohio 44307
Cincinnati, Ohio 45219
Columbus, Ohio 43210
West Chester, Ohio 45069
Oklahoma City, Oklahoma 73104
Providence, Rhode Island 02905
Site Public Contact
401-274-1122
Angleton, Texas 77515
Conroe, Texas 77384
Dallas, Texas 75235
Dallas, Texas 75390
Galveston, Texas 77555-0565
Houston, Texas 77030
Houston, Texas 77079
League City, Texas 77573
League City, Texas 77573
Site Public Contact
800-917-8906
Sugar Land, Texas 77478
Grafton, Wisconsin 53024
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53233
West Allis, Wisconsin 53227
More Details
- NCT ID
- NCT03927027
- Status
- 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.