Breast Cancer Clinical Trial
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
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.
Full 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.
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).
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There are 87 Locations for this study
Little Rock Arkansas, 72205, United States More Info
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La Jolla California, 92093, United States More Info
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Martinez California, 94553, United States More Info
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Oakland California, 94609, United States
Santa Monica California, 90404, United States More Info
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Frankford Delaware, 19945, United States More Info
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Newark Delaware, 19713, United States More Info
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Newark Delaware, 19718, United States More Info
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Rehoboth Beach Delaware, 19971, United States More Info
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Coral Gables Florida, 33146, United States More Info
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Deerfield Beach Florida, 33442, United States More Info
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Fort Lauderdale Florida, 33308, United States More Info
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Gainesville Florida, 32610, United States More Info
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Jacksonville Florida, 32207, United States More Info
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Jacksonville Florida, 32224, United States More Info
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Miami Florida, 33136, United States More Info
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Miami Florida, 33176, United States More Info
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Orlando Florida, 32806, United States More Info
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Plantation Florida, 33324, United States More Info
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Fayetteville Georgia, 30214, United States More Info
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Chicago Illinois, 60612, United States More Info
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Oak Lawn Illinois, 60453, United States More Info
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Goshen Indiana, 46526, United States More Info
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Kansas City Kansas, 66160, United States More Info
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Overland Park Kansas, 66211, United States More Info
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Westwood Kansas, 66205, United States More Info
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Louisville Kentucky, 40202, United States
Annapolis Maryland, 21401, United States More Info
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Bay City Michigan, 48706, United States
Clinton Township Michigan, 48038, United States More Info
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Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States More Info
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Farmington Hills Michigan, 48334, United States
West Bloomfield Michigan, 48322, United States More Info
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Wyandotte Michigan, 48192, United States More Info
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Camden New Jersey, 08103, United States More Info
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Somerville New Jersey, 08876, United States More Info
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East Hills New York, 11548, United States More Info
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New York New York, 10032, United States More Info
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Rochester New York, 14623, United States More Info
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Rochester New York, 14642, United States More Info
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West Islip New York, 11795, United States More Info
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Chapel Hill North Carolina, 27599, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Akron Ohio, 44307, United States More Info
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Beachwood Ohio, 44122, United States More Info
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Cincinnati Ohio, 45219, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Columbus Ohio, 43210, United States More Info
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Columbus Ohio, 43213, United States More Info
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Mentor Ohio, 44060, United States More Info
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Middleburg Heights Ohio, 44130, United States More Info
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Parma Ohio, 44129, United States More Info
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Ravenna Ohio, 44266, United States More Info
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Sandusky Ohio, 44870, United States More Info
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Wadsworth Ohio, 44281, United States More Info
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West Chester Ohio, 45069, United States More Info
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Westlake Ohio, 44145, United States More Info
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Westlake Ohio, 44145, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Philadelphia Pennsylvania, 19107, United States More Info
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Pittsburgh Pennsylvania, 15232, United States More Info
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Wilkes-Barre Pennsylvania, 18711, United States
Wilkes-Barre Pennsylvania, 18765, United States
Providence Rhode Island, 02905, United States More Info
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Angleton Texas, 77515, United States More Info
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Conroe Texas, 77384, United States More Info
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Dallas Texas, 75235, United States More Info
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Dallas Texas, 75390, United States More Info
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Galveston Texas, 77555, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77079, United States More Info
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League City Texas, 77573, United States More Info
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League City Texas, 77573, United States More Info
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Sugar Land Texas, 77478, United States More Info
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Richmond Virginia, 23235, United States More Info
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Richmond Virginia, 23298, United States More Info
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Issaquah Washington, 98029, United States More Info
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Seattle Washington, 98122, United States More Info
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Brookfield Wisconsin, 53045, United States More Info
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Grafton Wisconsin, 53024, United States More Info
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Green Bay Wisconsin, 54311, United States More Info
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Milwaukee Wisconsin, 53215, United States More Info
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Milwaukee Wisconsin, 53233, United States More Info
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Wauwatosa Wisconsin, 53226, United States More Info
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West Allis Wisconsin, 53227, United States More Info
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