Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-02-10 @ 11:23 AM
Study NCT ID:
NCT03927027
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025484', 'term': 'iso-sulfan blue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2019-04-23', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of upper extremity (UE) lymphedema', 'timeFrame': 'Up to 36 months post surgery', '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."}], 'secondaryOutcomes': [{'measure': 'Change in health-related quality of life: LSIDS-A questionnaire scores', 'timeFrame': 'Baseline to 36 months', '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.'}, {'measure': 'Incidence of regional recurrence', 'timeFrame': 'Up to 3 years', '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.'}, {'measure': '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)', 'timeFrame': 'Up to 3 years', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Stage I', 'Breast Cancer Stage II', 'Breast Cancer Stage III']}, 'referencesModule': {'references': [{'pmid': '36696330', 'type': 'DERIVED', 'citation': 'Levy AS, Murphy AI, Ishtihar S, Peysakhovich A, Taback B, Grant RT, Ascherman JA, Feldman S, Rohde CH. Lymphatic Microsurgical Preventive Healing Approach for the Primary Prevention of Lymphedema: A 4-Year Follow-Up. Plast Reconstr Surg. 2023 Feb 1;151(2):413-420. doi: 10.1097/PRS.0000000000009857. Epub 2022 Nov 15.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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).\n\nSECONDARY OBJECTIVES:\n\nI. 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).\n\nII. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.\n\nIII. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.\n\nEXPLORATORY OBJECTIVES:\n\nI. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).\n\nGROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.\n\nAfter completion of study, patients are followed up for 3 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:\n\n * 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.\n * Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.\n * Patients will be staged according to the TNM staging system.\n* Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.\n\n o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.\n* 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).\n* No bilateral invasive breast cancer.\n* No matted nodes.\n* No history of lymphedema of either arm.\n* No known allergies blue dyes, including make-up containing blue dye.\n* In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.\n* Female :\n\nMen 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.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n* Creatinine: =\\< 1.5 x upper limit of normal (ULN).'}, 'identificationModule': {'nctId': 'NCT03927027', 'briefTitle': 'Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A221702'}, 'secondaryIdInfos': [{'id': 'NCI-2018-02445', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program'}, {'id': 'UG1CA189823', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189823', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (ALND)', 'description': 'Patients receive isosulfan blue SC and undergo ALND.', 'interventionNames': ['Drug: Isosulfan Blue', 'Procedure: Axillary Lymph Node Dissection', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (ARM, ALND)', 'description': 'Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.', 'interventionNames': ['Drug: Isosulfan Blue', 'Procedure: Axillary Lymph Node Dissection', 'Procedure: Mapping', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Isosulfan Blue', 'type': 'DRUG', 'description': 'Given SC', 'armGroupLabels': ['Group I (ALND)', 'Group II (ARM, ALND)']}, {'name': 'Axillary Lymph Node Dissection', 'type': 'PROCEDURE', 'otherNames': ['ALND', 'axillary dissection'], 'description': 'Undergo ALND', 'armGroupLabels': ['Group I (ALND)', 'Group II (ARM, ALND)']}, {'name': 'Mapping', 'type': 'PROCEDURE', 'description': 'Undergo ARM', 'armGroupLabels': ['Group II (ARM, ALND)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (ALND)', 'Group II (ARM, ALND)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (ALND)', 'Group II (ARM, ALND)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94553-3156', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Regional Medical Center', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Summit Campus', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "Saint John's Cancer Institute", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '81632', 'city': 'Edwards', 'state': 'Colorado', 'country': 'United States', 'facility': 'Shaw Cancer Center', 'geoPoint': {'lat': 39.64499, 'lon': -106.5942}}, {'zip': '19945', 'city': 'Frankford', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe South Coastal Health Campus', 'geoPoint': {'lat': 38.51734, 'lon': -75.23491}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Helen F Graham Cancer Center', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System-Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19971', 'city': 'Rehoboth Beach', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Health Campus', 'geoPoint': {'lat': 38.72095, 'lon': -75.07601}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'UM Sylvester Comprehensive Cancer Center at Coral Gables', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33442', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'UM Sylvester Comprehensive Cancer Center at Deerfield Beach', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Science Center - Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist MD Anderson Cancer Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, 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'facility': 'University of Kansas Hospital-Indian Creek Campus', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital-Westwood Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The James Graham Brown Cancer Center at University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'McLaren Cancer Institute-Bay City', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 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'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel East Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Seidman Cancer Center at Lake Health Mentor Campus', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'UH Seidman Cancer Center at Southwest General Hospital', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '43054', 'city': 'New Albany', 'state': 'Ohio', 'country': 'United States', 'facility': 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