Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT00945061
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D018270', 'term': 'Carcinoma, Ductal, Breast'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D044584', 'term': 'Carcinoma, Ductal'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Janice.Lyons@uhhospitals.org', 'phone': '+1 216-844-2536', 'title': 'Dr. Janice A. Lyons, MD', 'organization': 'University Hospitals Cleveland Medical Center , Case Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 5 years', 'eventGroups': [{'id': 'EG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Hemorrhage, pulmonary/upper respiratory - nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Breast indentation/dimpling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Skin retraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Skin dimpling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Induration/fibrosis (skin and subcutaneous tissue)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Rash: dermatitis associated with radiation - Radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Telangiectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Heartburn/dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Breast Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Edema: limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Edema: trunk/genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Lymphatics: seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Glucose, serum-low (hypoglycemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Arthritis (non-septic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Extremity-lower (gait/walking)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Fibrosis-cosmesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Joint-function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Superficial soft tissue breast fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Mood alteration - Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Neuropathy: sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Dental/teeth/peridontal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Extremity-limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Joint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Pain - Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Nasal cavity/paranasal sinus reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Breast nipple/areolar deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Nipple Inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}, {'term': 'Intra-operative injury - Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE V3'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after radiation therapy (RT)', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). 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IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Ipsilateral Breast Tumor Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). 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IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Tumor Bed Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.\n\nIntraoperative radiation therapy: Patients undergo radiotherapy'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions 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radiotherapy'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.\n\nintracavitary balloon brachytherapy: Patients undergo brachytherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Tumor Bed Recurrence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.\n\nIntraoperative radiation therapy: Patients undergo radiotherapy'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.\n\nintracavitary balloon brachytherapy: Patients undergo brachytherapy'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Cosmetic Outcome as Determined by an Established Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': '1 Month', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG002', 'title': '3 Months', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG003', 'title': '6 Month', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG004', 'title': '9 Months', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG005', 'title': '12 Months', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG006', 'title': '5 Years', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after RT & Q3mos for one year and at 5 years', 'description': 'Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, 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I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants enrolled in study'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'OG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. 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I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. 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'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intraoperative Radiation Therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.'}, {'id': 'BG001', 'title': 'Intracavitary Balloon Brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 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'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2009-05-29', 'size': 240012, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-20T11:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2009-07-22', 'resultsFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '1 month after radiation therapy (RT)', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '3 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '6 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '9 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '12 months after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '2 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '3 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '4 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Ipsilateral Breast Tumor Recurrence Rates', 'timeFrame': '5 years after RT', 'description': 'Percent of participants with Ipsilateral breast tumor recurrence (IBTR). IBTR includes: true recurrence (TR) thought to occur when residual cancer cells grow gradually to detectable size and new primary (NP) thought to be new cancer independently arising in the preserved breast.'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '1 month after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '3 month after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '6 month after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '12 month after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '2 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '3 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '4 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Tumor Bed Recurrence Rates', 'timeFrame': '5 years after RT', 'description': 'Percent of participants with tumor bed recurrence, defined as recurrence in the same quadrant as the surgical excision'}, {'measure': 'Cosmetic Outcome as Determined by an Established Scale', 'timeFrame': '1 month after RT & Q3mos for one year and at 5 years', 'description': 'Cosmetic outcome as determined by four-level scale of cosmetic outcome scale, with levels poor, fair, good, and excellent in increasingly positive outcomes.\n\nExcellent: Minimal or no difference in the size or shape of the treated breast Good: Slight difference in the size or shape of the treated breast Fair: Obvious difference in the shape and size of the treated breast Poor: Obvious difference in the shape and size of the treated breast'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '1 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '3 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '6 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '9 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '12 month after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '2 years after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '3 years after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '4 years after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Indicating Total Satisfaction or Not Totally Satisfied But Would Choose Same Treatment Again on Quality of Life (QOL) Survey', 'timeFrame': '5 years after RT', 'description': 'Percent of participants indicating total satisfaction or not totally satisfied but would choose same treatment again on QOL survey\n\nParticipants indicate level of satisfaction by answering "my satisfaction about the treatment and results is"\n\n1. I am totally satisfied with the treatment and results\n2. I am not totally satisfied but would choose the same treatment again.\n3. I am not totally satisfied and would choose the standard 5-6 week course of radiation if I had it to do all over again.\n4. I am dissatisfied with my treatment.'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '1 month after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '3 month after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '6 month after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '9 month after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '12 month after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '2 years after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '3 years after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '4 years after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}, {'measure': 'Percent of Participants Experiencing Complications After Intervention', 'timeFrame': '5 years after RT', 'description': 'Overall complication rate, as measured by percent of participants experiencing complications after intervention'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '1 month after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '3 month after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '6 month after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '9 month after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '12 month after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '2 years after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '3 years after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '4 years after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}, {'measure': 'Percent of Participants With Delayed Wound Healing', 'timeFrame': '5 years after RT', 'description': 'Wound healing rate, as measured by percent of participants with delayed wound healing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ductal breast carcinoma in situ', 'recurrent breast cancer', 'invasive ductal breast carcinoma', 'medullary ductal breast carcinoma with lymphocytic infiltrate', 'mucinous ductal breast carcinoma', 'papillary ductal breast carcinoma', 'tubular ductal breast carcinoma', 'male breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.\n\nPURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.\n* To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.\n* To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.\n* To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.\n* To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.\n* To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.\n\nOUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.\n\nAll patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins \\< 2 mm undergo re-excision of the biopsy cavity.\n\n* Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.\n* Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.\n\nQuality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.\n\nAfter completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.\n* Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)\n* Unifocal breast cancer recurrence\n* Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision\n* Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.\n* Signed study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* Patients with distant metastatic disease\n* Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.\n* Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.\n* Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is Ductal carcinoma in situ (DCIS) and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.\n* Patients with Paget's disease of the nipple.\n* Patients with skin involvement.\n* Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.\n* Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.\n* Other malignancy, except non-melanomatous skin cancer, \\< 5 years prior to participation in this study.\n* Patients who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.\n* Patients with known BReast CAncer gene (BRCA)1/BRCA 2 mutations."}, 'identificationModule': {'nctId': 'NCT00945061', 'briefTitle': 'Radiation Therapy in Treating Patients With Recurrent Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation', 'orgStudyIdInfo': {'id': 'CASE11107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoperative radiation therapy', 'description': 'Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.', 'interventionNames': ['Radiation: intraoperative radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Intracavitary balloon brachytherapy', 'description': 'Patients undergo partial breast irradiation delivered as MammoSite® brachytherapy consisting of 10 fractions over 5 days.', 'interventionNames': ['Radiation: intracavitary balloon brachytherapy']}], 'interventions': [{'name': 'intracavitary balloon brachytherapy', 'type': 'RADIATION', 'description': 'Patients undergo brachytherapy', 'armGroupLabels': ['Intracavitary balloon brachytherapy']}, {'name': 'intraoperative radiation therapy', 'type': 'RADIATION', 'description': 'Patients undergo radiotherapy', 'armGroupLabels': ['Intraoperative radiation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Chagrin Highlands Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44145', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'UHHS Westlake Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Janice Lyons, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}