search
Back to results

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

Primary Purpose

Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Isosulfan Blue
Axillary Lymph Node Dissection
Mapping
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Stage I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

Group I (ALND)

Group II (ARM, ALND)

Arm Description

Patients receive isosulfan blue SC and undergo ALND.

Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.

Outcomes

Primary Outcome Measures

Incidence of upper extremity (UE) lymphedema
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

Change in health-related quality of life: LSIDS-A questionnaire scores
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
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.
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)
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.

Full Information

First Posted
April 23, 2019
Last Updated
September 13, 2023
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03927027
Brief Title
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
Official Title
ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (ALND)
Arm Type
Active Comparator
Arm Description
Patients receive isosulfan blue SC and undergo ALND.
Arm Title
Group II (ARM, ALND)
Arm Type
Experimental
Arm Description
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
Intervention Type
Drug
Intervention Name(s)
Isosulfan Blue
Intervention Description
Given SC
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Dissection
Other Intervention Name(s)
ALND, axillary dissection
Intervention Description
Undergo ALND
Intervention Type
Procedure
Intervention Name(s)
Mapping
Intervention Description
Undergo ARM
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Incidence of upper extremity (UE) lymphedema
Description
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.
Time Frame
Up to 36 months post surgery
Secondary Outcome Measure Information:
Title
Change in health-related quality of life: LSIDS-A questionnaire scores
Description
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.
Time Frame
Baseline to 36 months
Title
Incidence of regional recurrence
Description
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.
Time Frame
Up to 3 years
Title
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)
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
V. Suzanne Klimberg, MD, PhD
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Saint John's Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Shaw Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Beebe South Coastal Health Campus
City
Frankford
State/Province
Delaware
ZIP/Postal Code
19945
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Plantation
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453-2699
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Hospital-Indian Creek Campus
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
McLaren Cancer Institute-Bay City
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Henry Ford Macomb Hospital-Clinton Township
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Henry Ford Wyandotte Hospital
City
Wyandotte
State/Province
Michigan
ZIP/Postal Code
48192
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Sidney Kimmel Cancer Center Washington Township
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Robert Wood Johnson University Hospital Somerset
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Cancer Institute at Saint Francis Hospital
City
East Hills
State/Province
New York
ZIP/Postal Code
11548
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pluta Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Good Samaritan Hospital Medical Center
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Geauga Hospital
City
Chardon
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mount Carmel East Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
UH Seidman Cancer Center at Lake Health Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
UH Seidman Cancer Center at Southwest General Hospital
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Mount Carmel New Albany Surgical Hospital
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
University Hospitals Parma Medical Center
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
University Hospitals Portage Medical Center
City
Ravenna
State/Province
Ohio
ZIP/Postal Code
44266
Country
United States
Facility Name
UH Seidman Cancer Center at Firelands Regional Medical Center
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
University Hospitals Sharon Health Center
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
University of Cincinnati Cancer Center-West Chester
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
UH Seidman Cancer Center at Saint John Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Geisinger South Wilkes-Barre
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18765
Country
United States
Facility Name
Asplundh Cancer Pavilion
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
UTMB Health Angleton Danbury Campus
City
Angleton
State/Province
Texas
ZIP/Postal Code
77515
Country
United States
Facility Name
MD Anderson in The Woodlands
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson West Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
MD Anderson League City
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
UTMB Cancer Center at Victory Lakes
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
MD Anderson in Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
VCU Massey Cancer Center at Stony Point
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
City
Brookfield
State/Province
Wisconsin
ZIP/Postal Code
53045
Country
United States
Facility Name
Aurora Cancer Care-Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Ascension Medical Group Southeast Wisconsin - Mayfair Road
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

We'll reach out to this number within 24 hrs