Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection
- Conditions
- Breast Cancer Stage IIBreast Cancer Stage IBreast Cancer Stage III
- Interventions
- Procedure: Axillary Lymph Node DissectionOther: Quality-of-Life AssessmentProcedure: MappingOther: Questionnaire Administration
- Registration Number
- NCT03927027
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 534
-
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).
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I (ALND) Axillary Lymph Node Dissection Patients receive isosulfan blue SC and undergo ALND. Group II (ARM, ALND) Axillary Lymph Node Dissection Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. Group II (ARM, ALND) Questionnaire Administration Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. Group I (ALND) Quality-of-Life Assessment Patients receive isosulfan blue SC and undergo ALND. Group I (ALND) Questionnaire Administration Patients receive isosulfan blue SC and undergo ALND. Group II (ARM, ALND) Mapping Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. Group II (ARM, ALND) Quality-of-Life Assessment Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. Group II (ARM, ALND) Isosulfan Blue Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. Group I (ALND) Isosulfan Blue Patients receive isosulfan blue SC and undergo ALND.
- Primary Outcome Measures
Name Time Method Incidence of upper extremity (UE) lymphedema Up to 36 months post surgery Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire contains two different scales for intensity and distress measured from 1 (slight) to 5 (severe). The LSIDS-A questionnaire scores for swelling in the arm, decreased physical activity, pain in the arm, and loss of confidence in one's body will be evaluated for the change of baseline to 36 months using a two-sample, two-sided t-test.
- Secondary Outcome Measures
Name Time Method Technical success of performance of axillary reverse mapping (ARM) procedure (defined as identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics) Up to 3 years The cumulative incidence of regional recurrence will be summarized using the cumulative incidence function treating death without regional recurrence as the competing risk. Similar analysis methods described for the primary endpoint will be used to compare the cumulative incidence of regional recurrence between group I and II.
Change in health-related quality of life: LSIDS-A questionnaire scores Baseline to 36 months Will be assessed by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A questionnaire scores at each time point, as well as the change from baseline will be compared between groups by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), will use a non-parametric procedure such as Wilcoxon rank sum test. Further analysis will include linear mixed model using data from all time points to compare the LSIDS-A questionnaire scores between the two treatment groups over time adjusting for other baseline characteristics. Will evaluate the pattern of missing data. If the drop-out rate is higher than expected, methods proposed by Hogan and Laird will be used to assess whether the presence of drop-outs affects inferences obtained from the repeated measures analyses. Appropriate methods will be used to address missingness.
Incidence of regional recurrence Up to 3 years The technical success will be summarized using a binomial point estimate and 95% confidence interval (CI) and will be compared using a two-sample test of proportions.
Trial Locations
- Locations (96)
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Geisinger South Wilkes-Barre
🇺🇸Wilkes-Barre, Pennsylvania, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mount Carmel East Hospital
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI)
🇺🇸Pittsburgh, Pennsylvania, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Shaw Cancer Center
🇺🇸Edwards, Colorado, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
Helen F Graham Cancer Center
🇺🇸Newark, Delaware, United States
UM Sylvester Comprehensive Cancer Center at Plantation
🇺🇸Plantation, Florida, United States
Aurora Cancer Care-Grafton
🇺🇸Grafton, Wisconsin, United States
Ascension Medical Group Southeast Wisconsin - Mayfair Road
🇺🇸Wauwatosa, Wisconsin, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
🇺🇸Brookfield, Wisconsin, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
UM Sylvester Comprehensive Cancer Center at Kendall
🇺🇸Miami, Florida, United States
Beebe South Coastal Health Campus
🇺🇸Frankford, Delaware, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
🇺🇸Coral Gables, Florida, United States
University of Florida Health Science Center - Gainesville
🇺🇸Gainesville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
University of Cincinnati Cancer Center-UC Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Kansas Hospital-Indian Creek Campus
🇺🇸Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
🇺🇸Westwood, Kansas, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Saint John's Cancer Institute
🇺🇸Santa Monica, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Piedmont Fayette Hospital
🇺🇸Fayetteville, Georgia, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Pluta Cancer Center
🇺🇸Rochester, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Cancer Institute at Saint Francis Hospital
🇺🇸East Hills, New York, United States
Good Samaritan Hospital Medical Center
🇺🇸West Islip, New York, United States
UHHS-Chagrin Highlands Medical Center
🇺🇸Beachwood, Ohio, United States
Cleveland Clinic Akron General
🇺🇸Akron, Ohio, United States
Geauga Hospital
🇺🇸Chardon, Ohio, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
🇺🇸Mentor, Ohio, United States
University Hospitals Parma Medical Center
🇺🇸Parma, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
University of Cincinnati Cancer Center-West Chester
🇺🇸West Chester, Ohio, United States
University Hospitals Portage Medical Center
🇺🇸Ravenna, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center
🇺🇸Westlake, Ohio, United States
UHHS-Westlake Medical Center
🇺🇸Westlake, Ohio, United States
University Hospitals Sharon Health Center
🇺🇸Wadsworth, Ohio, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion
🇺🇸Willow Grove, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Swedish Cancer Institute-Issaquah
🇺🇸Issaquah, Washington, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
🇺🇸Houston, Texas, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
VCU Massey Cancer Center at Stony Point
🇺🇸Richmond, Virginia, United States
MD Anderson West Houston
🇺🇸Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center
🇺🇸Richmond, Virginia, United States
MD Anderson in Sugar Land
🇺🇸Sugar Land, Texas, United States
MD Anderson League City
🇺🇸League City, Texas, United States
Swedish Medical Center-First Hill
🇺🇸Seattle, Washington, United States
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
The James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
McLaren Cancer Institute-Bay City
🇺🇸Bay City, Michigan, United States
Aurora Sinai Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Weisberg Cancer Treatment Center
🇺🇸Farmington Hills, Michigan, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Henry Ford Macomb Hospital-Clinton Township
🇺🇸Clinton Township, Michigan, United States
Cooper Hospital University Medical Center
🇺🇸Camden, New Jersey, United States
Sidney Kimmel Cancer Center Washington Township
🇺🇸Sewell, New Jersey, United States
Henry Ford Wyandotte Hospital
🇺🇸Wyandotte, Michigan, United States
Robert Wood Johnson University Hospital Somerset
🇺🇸Somerville, New Jersey, United States
MD Anderson in The Woodlands
🇺🇸Conroe, Texas, United States
Mount Carmel New Albany Surgical Hospital
🇺🇸New Albany, Ohio, United States
UTMB Cancer Center at Victory Lakes
🇺🇸League City, Texas, United States
UH Seidman Cancer Center at Southwest General Hospital
🇺🇸Middleburg Heights, Ohio, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
UTMB Health Angleton Danbury Campus
🇺🇸Angleton, Texas, United States