Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-30 @ 4:48 AM
Study NCT ID:
NCT01622868
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seiferheldw@nrgoncology.org', 'phone': '215-574-3208', 'title': 'Wendy Seiferheld', 'organization': 'NRG Oncology'}, 'certainAgreement': {'otherDetails': "Must obtain prior approval from the sponsor. In addition, PI's are required to abide by the collaborator's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Weekly during radiation therapy and lapatinib (when applicable), 4 weeks post-RT completion, 12 weeks post-RT completion, every 3 months to year 3, and then annually. Maximum follow-up at time of analysis was 71.6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 49, 'seriousNumAtRisk': 63, 'deathsNumAffected': 48, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 63, 'seriousNumAtRisk': 71, 'deathsNumAffected': 53, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 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'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Response (CR) Rate in the Brain at 12 Weeks Post-radiation Therapy (RT) Using the RECIST 1.1 Criteria Based on Brain Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.10', 'groupDescription': 'The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks post RT (approximately 12 weeks from start of treatment if SRS and 15 if WBRT)', 'description': 'The Response Evaluation Criteria in Solid Tumors (RECIST) criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining the 12-week post-RT RECIST response was available for 52 eligible participants on the RT alone arm and 64 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate in the Brain at 4 Weeks Post-RT Using the RECIST 1.1 Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.10', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks post RT (approximately 4 weeks from start of treatment if SRS and 7 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining the 4-week post-RT RECIST response was available for 55 eligible participants on the RT alone arm and 67 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate in the Brain Using the World Health Organization (WHO)/Modified McDonald Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'title': '4 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.10', 'groupDescription': '4 weeks post-RT', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.10', 'groupDescription': '12 weeks post-RT', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The WHO/modified McDonald Criteria evaluates changes in bidimensional tumor measurements. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining the 4- and 12-week post-RT WHO response was available for 55 eligible participants at week 4 and 52 at week 12 on the RT alone arm and 67 at week 4 and 64 at week 12 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'title': '4 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '55.2', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Objective response is defined as a complete or partial response. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Partial response is defined as ≥ 30% reduction in the sum of diameters of up to 2 of the largest target lesions. Rate is calculated by dividing the number of patients with objective response by the number of analyzable patients.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining the 4- and 12-week post-RT RECIST response was available for 55 eligible participants at week 4 and 52 at week 12 on the RT alone arm and 67 at week 4 and 64 at week 12 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Progression in the Brain Outside the Targeted Measurable Disease Using the RECIST 1.1 Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '35.7'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '50.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. CNS progressive disease outside the targeted measureable disease was determined by a retrospective central review of MRI scans by the study neuroradiology co-chair and is defined as the first occurrence since baseline of new lesions or progression of non-target lesions. Time to CNS progressive disease is defined as time from randomization to the date of progressive disease, last known follow-up (censored), or death (competing risk). Progression rates are estimated using the cumulative incidence method. One-year rates are provided.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MRI scans were available for central review for progression outside targeted measurable disease for 41 eligible participants on the RT alone arm and 57 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Targeted Lesion-specific Objective Response Rate Using the RECIST 1.1 Measurement Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'title': '4 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '61.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Objective response is defined as a complete or partial response. Complete response is defined as the complete disappearance of all enhancing disease and partial response is defined as ≥ 30% reduction in the diameter of the target lesion. Lesions were evaluated individually. Rate is calculated by dividing the number of lesions with objective response by the number of analyzable lesions.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'Evaluable data for determining the 4- and 12-week post-RT RECIST target lesion measurement response was available for 51 eligible participants at week 4 and 43 at week 12 on the RT alone arm and 66 at week 4 and 57 at week 12 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Targeted Lesion-specific Progression Rate Using the RECIST 1.1 Measurement Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'title': '4 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}, {'title': '12 weeks post-RT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'lesions', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Progression is defined as ≥ 20% increase in the diameter of the target lesion relative to nadir. Lesions were evaluated individually. Rate is calculated by dividing the number of lesions with progression by the number of analyzable lesions.', 'unitOfMeasure': 'percentage of lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'Evaluable data for determining the 4- and 12-week post-RT RECIST target lesion measurement response was available for 51 eligible participants at week 4 and 43 at week 12 on the RT alone arm and 66 at week 4 and 57 at week 12 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Frequency of Highest Treatment-related Adverse Event Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to last follow-up. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'Adverse events reported as definitely, probably, or possibly related to protocol treatment. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data provided in this outcome measure. See Adverse Events Module for specific Adverse Event data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants who started study treatment and have adverse event data.'}, {'type': 'SECONDARY', 'title': 'Overall Complete Response Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'One-sided significance level = 0.10', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Overall complete response is defined as the complete disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically. All site-reported MRI data and all site-reporting of clinical progressive disease indicators were used in this analysis. Rate is calculated by dividing the number of participants with overall complete response by the number of analyzable participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining overall post-RT RECIST response was available for 54 eligible participants on the RT alone arm and 68 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Overall Progression Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Overall progression is defined as unequivocal progression, new or worsening tumor-related neurological symptoms, tumor-related increase in steroid dose, new primary in brain, or progression in target lesions. All site-reported MRI data and all site-reporting of clinical progressive disease indicators were used in this analysis. Rate is calculated by dividing the number of participants with progression by the number of analyzable participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable data for determining overall post-RT RECIST response was available for 54 eligible participants on the RT alone arm and 68 on the lapatinib arm.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'OG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '19.1'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '21.0'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.36', 'pValueComment': 'Two-sided significance level = 0.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to last follow-up. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 101 deaths were reported.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'FG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'Eligible, Started Study Treatment, Has Adverse Event Data', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'comment': 'Participants contributing data to results are considered to have completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiation Therapy', 'description': 'Stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT)'}, {'id': 'BG001', 'title': 'Lapatinib and Radiation Therapy', 'description': '1000 mg Lapatinib for six weeks with radiation therapy (stereotactic radiosurgery (SRS) or 3 weeks of whole brain radiotherapy (WBRT))'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 50 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '≥ 50 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Karnofsky Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': '60', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '70-80', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '90-100', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '60: Requires occasional assistance, but is able to care for most personal needs; 70: Cares for self, unable to carry on normal activity or do active work; 80: Normal activity with effort, some sign or symptoms of disease; 90: Able to carry on normal activity; minor signs or symptoms of disease; 100: Normal, no complaints, no evidence of disease.', 'unitOfMeasure': 'Participants'}, {'title': 'Graded Prognostic Assessment for Breast Cancer (Breast-GPA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': '1.5-2.0', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '2.5-3.0', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': '3.5-4.0', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Breast-GPA is defined by the combination of prognostic factors: breast tumor subtype, Karnofsky performance score (KPS), and age. Breast tumor subtype consists of the presence/absence of each of the following biomarkers: estrogen receptor, human epidermal growth factor receptor 2, and progesterone receptor. A lower GPA is associated with worse survival; a higher GPA is associated with better survival.', 'unitOfMeasure': 'Participants'}, {'title': 'Use of Non-central nervous system (CNS) penetrating HER2 Blockade at Study Entry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No (None)', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Yes (Trastuzumab and/or Pertuzumab)', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HER2: human epidermal growth factor receptor 2', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Stereotactic SRS or Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Eligible participants randomized before the October 2016 protocol amendment which removed this stratification factor.'}, {'title': 'Planned RT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}], 'categories': [{'title': 'SRS', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'WBRT', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Eligible participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-02', 'size': 1829690, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-16T14:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2012-06-15', 'resultsFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2012-06-15', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-18', 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response (CR) Rate in the Brain at 12 Weeks Post-radiation Therapy (RT) Using the RECIST 1.1 Criteria Based on Brain Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Baseline and 12 weeks post RT (approximately 12 weeks from start of treatment if SRS and 15 if WBRT)', 'description': 'The Response Evaluation Criteria in Solid Tumors (RECIST) criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate in the Brain at 4 Weeks Post-RT Using the RECIST 1.1 Criteria Based on Brain MRI', 'timeFrame': 'Baseline and 4 weeks post RT (approximately 4 weeks from start of treatment if SRS and 7 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.'}, {'measure': 'Complete Response Rate in the Brain Using the World Health Organization (WHO)/Modified McDonald Criteria Based on Brain MRI', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The WHO/modified McDonald Criteria evaluates changes in bidimensional tumor measurements. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Rate is calculated by dividing the number of patients with complete response by the number of analyzable patients.'}, {'measure': 'Objective Response Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Objective response is defined as a complete or partial response. Complete response is defined as the complete disappearance of all enhancing disease and off all steroids. Partial response is defined as ≥ 30% reduction in the sum of diameters of up to 2 of the largest target lesions. Rate is calculated by dividing the number of patients with objective response by the number of analyzable patients.'}, {'measure': 'Percentage of Participants With Progression in the Brain Outside the Targeted Measurable Disease Using the RECIST 1.1 Criteria Based on Brain MRI', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. CNS progressive disease outside the targeted measureable disease was determined by a retrospective central review of MRI scans by the study neuroradiology co-chair and is defined as the first occurrence since baseline of new lesions or progression of non-target lesions. Time to CNS progressive disease is defined as time from randomization to the date of progressive disease, last known follow-up (censored), or death (competing risk). Progression rates are estimated using the cumulative incidence method. One-year rates are provided.'}, {'measure': 'Targeted Lesion-specific Objective Response Rate Using the RECIST 1.1 Measurement Criteria Based on Brain MRI', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Objective response is defined as a complete or partial response. Complete response is defined as the complete disappearance of all enhancing disease and partial response is defined as ≥ 30% reduction in the diameter of the target lesion. Lesions were evaluated individually. Rate is calculated by dividing the number of lesions with objective response by the number of analyzable lesions.'}, {'measure': 'Targeted Lesion-specific Progression Rate Using the RECIST 1.1 Measurement Criteria Based on Brain MRI', 'timeFrame': 'Baseline, 4 and 12 weeks post RT (approximately 4 and 12 weeks from start of treatment if SRS, 7 and 15 if WBRT)', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Progression is defined as ≥ 20% increase in the diameter of the target lesion relative to nadir. Lesions were evaluated individually. Rate is calculated by dividing the number of lesions with progression by the number of analyzable lesions.'}, {'measure': 'Frequency of Highest Treatment-related Adverse Event Per Participant', 'timeFrame': 'From randomization to last follow-up. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'Adverse events reported as definitely, probably, or possibly related to protocol treatment. Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data provided in this outcome measure. See Adverse Events Module for specific Adverse Event data.'}, {'measure': 'Overall Complete Response Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Overall complete response is defined as the complete disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically. All site-reported MRI data and all site-reporting of clinical progressive disease indicators were used in this analysis. Rate is calculated by dividing the number of participants with overall complete response by the number of analyzable participants.'}, {'measure': 'Overall Progression Rate in the Brain Using the RECIST 1.1 Criteria Based on Brain MRI', 'timeFrame': 'From randomization to last follow-up. MRIs occurred at baseline, 4 and 12 weeks post RT, then every 12 weeks thereafter until progression. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'The RECIST criteria evaluates changes in the largest diameter (unidimensional measurement) of the tumor lesions. Overall progression is defined as unequivocal progression, new or worsening tumor-related neurological symptoms, tumor-related increase in steroid dose, new primary in brain, or progression in target lesions. All site-reported MRI data and all site-reporting of clinical progressive disease indicators were used in this analysis. Rate is calculated by dividing the number of participants with progression by the number of analyzable participants.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From randomization to last follow-up. Maximum follow-up at time of analysis was 71.6 months.', 'description': 'An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis occurred after 101 deaths were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HER2-Positive Breast Carcinoma', 'Invasive Breast Carcinoma', 'Metastatic Malignant Neoplasm in the Brain', 'Recurrent Breast Carcinoma', 'Stage IV Breast Cancer AJCC v6 and v7']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if there is a signal for an increase in complete response (CR) rate in the measurable brain metastases at 12 weeks post radiation therapy (RT) (whole brain or stereotactic radiosurgery \\[SRS\\]) as determined by magnetic-resonance imaging (MRI) scan of the brain, with the addition of lapatinib (lapatinib ditosylate) to whole-brain radiation therapy (WBRT)/SRS compared to WBRT/SRS alone.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate CR rate of the measurable brain metastases at 4 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nII. To evaluate objective response rate of measurable brain metastases at 4 and 12 weeks post RT (WBRT/SRS) as determined by MRI scan of the brain, with the addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nIII. To evaluate targeted lesion-specific objective response rate (CR + partial response \\[PR\\]) at 4 and 12 weeks post WBRT/SRS.\n\nIV. To evaluate central nervous system (CNS) progressive disease outside the targeted measurable disease with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nV. To evaluate targeted lesion-specific progression at 4 and 12 weeks post WBRT/SRS.\n\nVI. To evaluate treatment related adverse events when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nVII. To evaluate overall CNS complete response: disappearance of all CNS target lesions sustained for at least 4 weeks; with no new lesions, no use of corticosteroids, and patient is stable or improved clinically, when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nVIII. To evaluate overall CNS progressive disease (within or outside targeted measurable disease) with addition of lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nIX. To evaluate overall survival when adding lapatinib to WBRT/SRS compared to WBRT/SRS alone.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments or SRS for 1 treatment.\n\nARM B: Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate orally (PO) once daily (QD) for 6 weeks.\n\nAfter completion of study treatment, patients are followed up at 4 and 12 weeks and then every 12 weeks thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of invasive breast cancer\n* HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization \\[FISH\\] or silver in situ hybridization \\[SISH\\] \\>= 2.0)\n* At least 1 measurable unirradiated parenchymal brain metastasis within 21 days prior to study entry; patients who are to undergo SRS must have no more than 10 brain metastases; there is no limit on number of brain metastases for WBRT; the minimum size as measured on T1-weighted gadolinium-enhanced MRI must be as follows according to the number of brain metastases:\n\n * For a single solitary lesion the size must be \\>= 10 mm\n * For 2 or more lesions, the size of at least 2 of the lesions must be \\>= 5 mm\n * Patients may also have the following provided the size requirements above are met:\n\n * Progressive parenchymal brain metastasis following stereotactic radiosurgery for 1-3 brain metastases, with at least 1 new measurable brain lesion\n * Progressive parenchymal brain metastasis following surgical resection of 1-3 brain metastases, with at least 1 measurable brain lesion\n* History/physical examination within 21 days prior to study entry\n* Karnofsky performance status \\>= 60 within 21 days prior to study entry\n* Able to swallow and retain oral medication (note: for patients unable to swallow tablets, an oral suspension preparation is acceptable)\n* Absolute neutrophil count (ANC) \\>= 1,200 cells/mm\\^3 (within 21 days prior to study entry)\n* Platelets \\>= 70,000 cells/mm\\^3 (within 21 days prior to study entry)\n* Hemoglobin \\>= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 8.0 g/dL is acceptable) (within 21 days prior to study entry)\n* Creatinine \\< 1.5 times institutional upper limit of normal (within 21 days prior to study entry)\n* Bilirubin \\< 1.5 times institutional upper limit of normal (within 21 days prior to study entry)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\< 3.0 times institutional upper limit of normal with or without liver metastasis (within 21 days prior to study entry)\n* Patient must provide study specific informed consent prior to study entry\n* Women of childbearing potential must have a negative serum pregnancy test within 21 days prior to study entry\n* Sexually active women of childbearing potential and sexually active men must practice adequate contraception during therapy and for 12 months after protocol treatment completion\n* Prior lapatinib is allowed as long as the last dose received was \\> 21 days prior to study entry and provided the patient has not received it at any time after the diagnosis of brain metastasis\n\nExclusion Criteria:\n\n* Prior WBRT\n* Prior radiation therapy (RT) (any site) with concurrent lapatinib defined as 1 or more days on which the patient received both radiation therapy and lapatinib on the same day\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Prior invasive malignancy (except non-melanomatous skin cancer, curatively resected thyroid papillary carcinoma, and invasive and non-invasive cancers related to the breast cancer) unless disease free for a minimum of 3 years\n* Leptomeningeal disease\n* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields except patients who have progressed following stereotactic radiosurgery for 1-3 brain metastases, with at least one new lesion\n* Severe, active co-morbidity, defined as follows:\n\n * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\n * Transmural myocardial infarction within the last 6 months\n * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study entry\n * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry\n * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; hepatic or biliary disease that is acute or currently active or that requires antiviral therapy (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)\n * History of left ventricular ejection fraction (LVEF) below institutional normal unless repeated and within institutional normal range within 90 days of study entry\n* Grade 2 or greater rash of any cause at time of study entry\n* Grade 2 or greater diarrhea of any cause at time of study entry"}, 'identificationModule': {'nctId': 'NCT01622868', 'briefTitle': 'Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer - A Collaborative Study of NRG Oncology and KROG', 'orgStudyIdInfo': {'id': 'NCI-2012-01977'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01977', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'RTOG-1119'}, {'id': 'CDR0000735353'}, {'id': 'RTOG-1119', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'RTOG-1119', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}, {'id': 'U10CA021661', 'link': 'https://reporter.nih.gov/quickSearch/U10CA021661', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (WBRT or SRS)', 'description': 'Patients undergo WBRT 5 days a week for 3 weeks for a total of 15 treatments, or SRS for 1 treatment.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Radiation: Stereotactic Radiosurgery', 'Radiation: Whole-Brain Radiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (lapatinib ditosylate, WBRT or SRS)', 'description': 'Patients undergo WBRT or SRS as in Arm A. Patients also receive lapatinib ditosylate PO QD for 6 weeks.', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Drug: Lapatinib Ditosylate', 'Radiation: Stereotactic Radiosurgery', 'Radiation: Whole-Brain Radiotherapy']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (WBRT or SRS)', 'Arm B (lapatinib ditosylate, WBRT or SRS)']}, {'name': 'Lapatinib Ditosylate', 'type': 'DRUG', 'otherNames': ['Tykerb'], 'description': 'Given PO', 'armGroupLabels': ['Arm B (lapatinib ditosylate, WBRT or SRS)']}, {'name': 'Stereotactic Radiosurgery', 'type': 'RADIATION', 'otherNames': ['Stereotactic External Beam Irradiation', 'stereotactic external-beam radiation therapy', 'Stereotactic Radiation Therapy', 'Stereotactic Radiotherapy', 'stereotaxic radiation therapy', 'stereotaxic radiosurgery'], 'description': 'Undergo SRS', 'armGroupLabels': ['Arm A (WBRT or SRS)', 'Arm B (lapatinib ditosylate, WBRT or SRS)']}, {'name': 'Whole-Brain Radiotherapy', 'type': 'RADIATION', 'otherNames': ['WBRT', 'whole-brain radiation therapy'], 'description': 'Undergo WBRT', 'armGroupLabels': ['Arm A (WBRT or SRS)', 'Arm B (lapatinib ditosylate, WBRT or SRS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Kirklin Clinic at Acton Road', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Mitchell Cancer Institute', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Saint Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95602', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Auburn Faith Hospital', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '95603', 'city': 'Auburn', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Auburn', 'geoPoint': {'lat': 38.89657, 'lon': -121.07689}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center-Herrick Campus', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '95682', 'city': 'Cameron Park', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Centers Radiation Oncology Services-Cameron Park', 'geoPoint': {'lat': 38.66879, 'lon': -120.98716}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy San Juan Medical Center', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Davis Hospital', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care-Dublin', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Breast Surgeons Inc', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94608', 'city': 'Emeryville', 'state': 'California', 'country': 'United States', 'facility': 'Epic Care Partners in Cancer Care', 'geoPoint': {'lat': 37.83132, 'lon': -122.28525}}, {'zip': '94553-3156', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Contra Costa Regional Medical Center', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Camino Division', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation-Gynecologic Oncology', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94945', 'city': 'Novato', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Research Consortium', 'geoPoint': {'lat': 38.10742, 'lon': -122.5697}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center - Summit Campus', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Tumor Institute', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Medical Foundation Health Care', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United 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