Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
About this trial
This is an interventional prevention trial for Breast Cancer Stage I
Eligibility 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).
Sites / Locations
- University of Arkansas for Medical Sciences
- UC San Diego Moores Cancer Center
- Contra Costa Regional Medical Center
- Alta Bates Summit Medical Center - Summit Campus
- Saint John's Cancer Institute
- Shaw Cancer Center
- Beebe South Coastal Health Campus
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- UM Sylvester Comprehensive Cancer Center at Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
- Holy Cross Hospital
- University of Florida Health Science Center - Gainesville
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- UM Sylvester Comprehensive Cancer Center at Kendall
- Orlando Health Cancer Institute
- UM Sylvester Comprehensive Cancer Center at Plantation
- Piedmont Fayette Hospital
- Rush University Medical Center
- Advocate Christ Medical Center
- Goshen Center for Cancer Care
- University of Kansas Cancer Center
- University of Kansas Hospital-Indian Creek Campus
- University of Kansas Hospital-Westwood Cancer Center
- The James Graham Brown Cancer Center at University of Louisville
- Anne Arundel Medical Center
- McLaren Cancer Institute-Bay City
- Henry Ford Macomb Hospital-Clinton Township
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Weisberg Cancer Treatment Center
- Henry Ford West Bloomfield Hospital
- Henry Ford Wyandotte Hospital
- Cooper Hospital University Medical Center
- Sidney Kimmel Cancer Center Washington Township
- Robert Wood Johnson University Hospital Somerset
- Cancer Institute at Saint Francis Hospital
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Pluta Cancer Center
- University of Rochester
- Good Samaritan Hospital Medical Center
- UNC Lineberger Comprehensive Cancer Center
- Wake Forest University Health Sciences
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- Geauga Hospital
- University of Cincinnati Cancer Center-UC Medical Center
- Case Western Reserve University
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Mount Carmel New Albany Surgical Hospital
- University Hospitals Parma Medical Center
- University Hospitals Portage Medical Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- University Hospitals Sharon Health Center
- University of Cincinnati Cancer Center-West Chester
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- University of Oklahoma Health Sciences Center
- Penn Presbyterian Medical Center
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Geisinger Wyoming Valley/Henry Cancer Center
- Geisinger South Wilkes-Barre
- Asplundh Cancer Pavilion
- Women and Infants Hospital
- UTMB Health Angleton Danbury Campus
- MD Anderson in The Woodlands
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- University of Texas Medical Branch
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- M D Anderson Cancer Center
- MD Anderson West Houston
- MD Anderson League City
- UTMB Cancer Center at Victory Lakes
- MD Anderson in Sugar Land
- VCU Massey Cancer Center at Stony Point
- Virginia Commonwealth University/Massey Cancer Center
- Swedish Cancer Institute-Issaquah
- Swedish Medical Center-First Hill
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Ascension Medical Group Southeast Wisconsin - Mayfair Road
- Aurora West Allis Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group I (ALND)
Group II (ARM, ALND)
Patients receive isosulfan blue SC and undergo ALND.
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.