Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 7:09 PM
Study NCT ID:
NCT00005957
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2000-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'twhelan@HHSC.CA', 'phone': '1(905) 387-9495', 'title': 'Dr. Timothy J. Whelan', 'organization': 'Juravinski Cancer Centre at Hamilton Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 years', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Breast Irradiation', 'description': 'radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.\n\nAnalysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.', 'otherNumAtRisk': 927, 'otherNumAffected': 745, 'seriousNumAtRisk': 927, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Breast Radiation Plus Regional Radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.\n\nAnalysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.', 'otherNumAtRisk': 893, 'otherNumAffected': 752, 'seriousNumAtRisk': 893, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 226}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 353}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 343}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain due to radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 233}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 89}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 313}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 316}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Subcutaneous tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 180}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Radiation dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 130}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 157}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 217}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 218}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neuropathic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 96}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gynecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 283}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 256}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 116}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 150}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hot flashes/ flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 53}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Secondary Malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 927, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 893, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '916', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Breast Irradiation', 'description': 'radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.'}, {'id': 'OG001', 'title': 'Breast Radiation Plus Regional Radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '84'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.13', 'estimateComment': 'Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.', 'groupDescription': 'It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '10 years', 'description': 'Duration of study', 'unitOfMeasure': 'percentage of alive at 10 years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'OG000'}, {'value': '916', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Breast Irradiation', 'description': 'radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.'}, {'id': 'OG001', 'title': 'Breast Radiation Plus Regional Radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '74', 'upperLimit': '80'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '79', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '10 years', 'description': 'Disease-free survival (including locoregional and distant disease)', 'unitOfMeasure': 'percentage of disease-free at 10 years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Breast Irradiation', 'description': 'radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.'}, {'id': 'FG001', 'title': 'Breast Radiation Plus Regional Radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '916'}, {'groupId': 'FG001', 'numSubjects': '916'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '908'}, {'groupId': 'FG001', 'numSubjects': '888'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'No treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Crossover to the other arm', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '916', 'groupId': 'BG000'}, {'value': '916', 'groupId': 'BG001'}, {'value': '1832', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Breast Irradiation', 'description': 'radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.'}, {'id': 'BG001', 'title': 'Breast Radiation Plus Regional Radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '10', 'groupId': 'BG000'}, {'value': '54', 'spread': '10', 'groupId': 'BG001'}, {'value': '54', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '916', 'groupId': 'BG000'}, {'value': '916', 'groupId': 'BG001'}, {'value': '1832', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention-to-treat'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1832}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2000-07-05', 'resultsFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-09', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '10 years', 'description': 'Duration of study'}], 'secondaryOutcomes': [{'measure': 'Disease-free Survival', 'timeFrame': '10 years', 'description': 'Disease-free survival (including locoregional and distant disease)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '26200977', 'type': 'RESULT', 'citation': 'Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340.'}, {'pmid': '31085285', 'type': 'DERIVED', 'citation': 'Gross JP, Whelan TJ, Parulekar WR, Chen BE, Rademaker AW, Helenowski IB, Donnelly ED, Strauss JB. Development and Validation of a Nomogram to Predict Lymphedema After Axillary Surgery and Radiation Therapy in Women With Breast Cancer From the NCIC CTG MA.20 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):165-173. doi: 10.1016/j.ijrobp.2019.05.002. Epub 2019 May 11.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer.\n\nPURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the overall survival, disease-free survival, isolated local regional disease-free survival, and distant disease-free survival in women with previously resected, early stage, invasive breast cancer treated with breast radiotherapy with or without regional radiotherapy.\n* Compare the toxic effects of these regimens in these patients.\n* Compare the quality of life of patients (in certain participating centers) treated with these regimens.\n* Compare the cosmetic outcomes in patients (in certain participating centers) treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs more than 3), number of axillary nodes removed (\\<10, \\> or equal to 10); type of chemotherapy (anthracycline containing vs other vs none), hormonal therapy (yes vs no), number of axillary lymph nodes excised\\*, and participating center. Patients are randomized to one of two treatment arms.\n\nNOTE: \\* Patients with a negative sentinel node dissection with or without an axillary dissection will be stratified according to the total number of nodes removed\n\n* Arm I: Patients undergo standard breast radiotherapy alone 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients undergo breast and regional radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.\n\nRadiotherapy in both arms begins as soon as possible after randomization. Radiotherapy must begin within 8 weeks after completion of adjuvant IV chemotherapy, unless radiotherapy is administered concurrently with chemotherapy (i.e., cyclophosphamide, methotrexate, and fluorouracil \\[CMF\\]), or within 16 weeks after the last breast surgery for patients treated with hormonal therapy alone.\n\nQuality of life is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, during the last week of radiotherapy, at 3 and 9 months after completion of radiotherapy, and then annually until first distant disease recurrence.\n\nCosmetic outcome is assessed (in patients in certain participating centers) within 2 weeks prior to randomization, and then at 3 and 5 years after completion of radiotherapy or until first distant disease recurrence.\n\nPatients are followed at 3, 6, and 9 months, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 1,822 patients will be accrued for this study within approximately 4 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven invasive carcinoma of the breast\n\n * No evidence of T4, N2-3, or M1 disease prior to surgery\n * Node positive or high-risk node negative\n* Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT\n\n * Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision\n * Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site\n * Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria\n\n * If node positive, then a level I and II axillary dissection must be performed\n * No evidence of residual disease in axilla after dissection\n* Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy\n* High risk of regional and systemic recurrence due to one of the following:\n\n * Pathologically positive axillary lymph nodes\n * Pathologically negative axillary lymph nodes with one of the following:\n\n * Primary tumor greater than 5 cm\n * Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:\n\n * Estrogen receptor negative\n * Skarf-Bloom-Richardson grade 3\n * Lymphovascular invasion\n* Hormone receptor status:\n\n * Estrogen and progesterone receptor status known\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 16 and over\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Premenopausal or postmenopausal\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 5 years\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)\\*\n* Alkaline phosphatase no greater than 3 times ULN\\* NOTE: \\* Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations\n\nRenal:\n\n* No serious nonmalignant renal disease\n\nCardiovascular:\n\n* No serious nonmalignant cardiovascular disease\n\nPulmonary:\n\n* No serious nonmalignant pulmonary disease\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy\n* No other malignancy except:\n\n * Nonmelanomatous skin cancer\n * Carcinoma in situ of the cervix or endometrium\n * Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)\n * Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation\n* No psychiatric or addictive disorder that would preclude informed consent or study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* Concurrent standard adjuvant chemotherapy allowed\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* Concurrent standard adjuvant hormonal therapy allowed\n\nRadiotherapy:\n\n* See Disease Characteristics\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00005957', 'briefTitle': 'Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase III Study of Regional Radiation Therapy in Early Breast Cancer', 'orgStudyIdInfo': {'id': 'MA20'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-MA20'}, {'id': 'NSABP-CAN-NCIC-MA20', 'type': 'OTHER', 'domain': 'NSABP'}, {'id': 'NCCTG-CAN-NCIC-MA20', 'type': 'OTHER', 'domain': 'NCCTG'}, {'id': 'RTOG-CAN-NCIC-MA20', 'type': 'OTHER', 'domain': 'RTOG'}, {'id': 'SWOG-CAN-NCIC-MA20', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'TROG-CAN-NCIC-MA20', 'type': 'OTHER', 'domain': 'TROG'}, {'id': 'CDR0000067938', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Breast Irradiation', 'interventionNames': ['Radiation: Standard Breast Irradiation']}, {'type': 'EXPERIMENTAL', 'label': 'Breast Radiation plus regional radiation', 'description': 'regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)', 'interventionNames': ['Radiation: Breast Radiation plus Regional Radiation']}], 'interventions': [{'name': 'Standard Breast Irradiation', 'type': 'RADIATION', 'description': 'Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.', 'armGroupLabels': ['Standard Breast Irradiation']}, {'name': 'Breast Radiation plus Regional Radiation', 'type': 'RADIATION', 'description': 'Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.', 'armGroupLabels': ['Breast Radiation plus regional radiation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3V 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