Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT03422003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2018-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rpunglia@mgb.org', 'phone': '617-632-3591', 'title': 'Dr. Rinaa Punglia', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected if they occurred any time between initiation of protocol treatment and 3-years after the initiation of protocol treatment. All AEs reported throughout the study period are presented below in the data tables. Sites were asked to only report events listed in the Adverse Event Reporting Description. Some AEs below never occurred during the study period. Additional AEs that did not fall into these categories were also collected and reported.', 'description': 'Reportable AEs include:\n\n* Grade 1, 2, or 3 brachial plexopathy\n* Grade 3 chest wall pain\n* Grade 3 lymphedema\n* Grade 3, 4, or 5 myocardial infarction\n* Grade 1, 2, 3, 4, or 5 pneumonitis\n* Grade 3, 4, or 5 treatment related secondary malignancy\n* Grade 3, 4, or 5 wound infection\n* Unexpected grade 3 or 4 with a possible, probable, or definite attribution to radiation therapy\n* Grade 5 (death): all deaths', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Hypofractionation', 'description': '16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 4, 'seriousNumAtRisk': 199, 'deathsNumAffected': 2, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Arm 2: Conventional Radiation Therapy', 'description': '25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 2, 'seriousNumAtRisk': 201, 'deathsNumAffected': 2, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Dehisence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}, {'term': 'Capsular Contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}], 'seriousEvents': [{'term': 'Distant recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}, {'term': 'Local-regional recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}, {'term': 'Infection', 'notes': 'Breast or wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v 4.03'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Reported Outcomes Using the FACT-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Hypofractionation', 'description': '16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}, {'id': 'OG001', 'title': 'Arm 2: Conventional Radiation Therapy', 'description': '25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}], 'classes': [{'title': 'Baseline FACT-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104.3', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '102.4', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline PWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline SWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline EWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline FWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline BCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '24.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': '6-month FACT-B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105.0', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '103.5', 'spread': '17.7', 'groupId': 'OG001'}]}]}, {'title': '6-month PWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': '6-month SWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.4', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': '6-month EWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': '6-month FWB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': '6-month BCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.4', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life.\n\nScore ranges:\n\n* The score range for the FACT-B total score is 0-148.\n* The score range for the PWB, social/family well-being (SWB), and functional well-being (FWB) subscales is 0-28.\n* The score range for the emotional well-being (EWB) subscale is 0-24.\n* The score range for the breast cancer subscale (BCS) is 0-40.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants skipped the survey questions related to the primary outcome being analyzed. This is why there is a discrepancy between the number analyzed for each domain and the total number of participants in each arm.'}, {'type': 'SECONDARY', 'title': 'Oncologic and Clinical Outcomes Assessed Using Medical Record Abstractions.', 'timeFrame': '10 years', 'description': 'Clinical and oncologic outcomes (rare radiation side effects, recurrence, infections, additional surgeries) will be assessed over a period of 10 years through annual medical record abstractions.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cosmetic Outcomes Assessed Using Photographic Evaluations.', 'timeFrame': '18 months', 'description': 'Cosmetic outcomes (quality of reconstructive surgery throughout and after radiation therapy) will be assessed from baseline to 18 months by trained physicians using a standardized rating scale.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Hypofractionation', 'description': '16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}, {'id': 'FG001', 'title': 'Arm 2: Conventional Radiation Therapy', 'description': '25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Some participants skipped the survey question related to the primary outcome being analyzed.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': '6-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Withdrawal by subject, loss to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '33'}]}]}], 'preAssignmentDetails': 'The following are reasons for withdrawal from the study before starting protocol treatment:\n\n* patients withdrew due to the treatment arm assignment\n* patients withdrew due to a change in treatment site\n* clinician withdrew patients due to tissue expander removal and other treatment needs'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Hypofractionation', 'description': '16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}, {'id': 'BG001', 'title': 'Arm 2: Conventional Radiation Therapy', 'description': '25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.\n\nRadiation Therapy: For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': '<40 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '40-50 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': '51-60 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': '60+ years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', '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': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '354', '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': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '33', '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': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '318', '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': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No College', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Some college', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'College graduate', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Some graduate/graduate degree', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': '<20 (kg/m^2)', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '20.0-24.9 (kg/m^2)', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': '25.0-29.9 (kg/m^2)', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': '30.0-34.9 (kg/m^2)', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Greater than or equal to 35.0 (kg/m^2)', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}, {'title': 'Current/Former Smoker', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Infection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Laterality', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Laterality: Right', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Laterality: Left', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hormone Receptor Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A pathologist tests the surgical specimen for expression of hormone receptors, like estrogen or progesterone.', 'unitOfMeasure': 'Participants'}, {'title': 'HER2 Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Equivocal', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}, {'title': 'Positive', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HER2 is a gene. To determine the HER2 status of breast cancer, a tumor sample is tested for either the number of copies of the HER2 gene, or for the amount of HER2 protein.', 'unitOfMeasure': 'Participants'}, {'title': 'Histology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Invasive Ductal', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': 'Invasive Lobular', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Both', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Grade', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Poorly Differentiated (Grade 3)', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Moderately Differentiated (Grade 2)', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'Well Differentiated (Grade 1)', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not applicable', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'A pathologist looks at tumor samples under a microscope to see how much the cancer cells look like normal cells. If a tumor sample gets a low grade, those cells look more like normal breast cells. If a tumor sample gets a high grade, those cells look very different than normal breast cells.', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor Size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than or equal to 2 cm', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}, {'title': 'Greater than 2 cm - Less than or equal to 5 cm', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Greater than 5cm', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lymphatic Vessel Invasion (LVI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Negative', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total number of positive nodes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': '0 nodes', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': '1 node', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': '2 nodes', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': '3 or more nodes', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Axillary Node Dissection', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Axillary Nodes Removed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '9.0', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '27'}, {'value': '9', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Nodes', 'dispersionType': 'FULL_RANGE'}, {'title': 'Location of Device', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Pre-pectoral', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Sub-pectoral', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Not applicable/Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In this study, participants underwent immediate reconstructive surgery with placement of either a tissue expander or permanent implant at the time of mastectomy. "Device" refers to either the tissue expander or permanent implant.', 'unitOfMeasure': 'Participants'}, {'title': 'Device irradiated', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Expander', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}]}, {'title': 'Implant', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In this study, participants underwent immediate reconstructive surgery with placement of either a tissue expander or permanent implant at the time of mastectomy. "Device" refers to either the tissue expander or permanent implant.', 'unitOfMeasure': 'Participants'}, {'title': 'Neoadjuvant Chemotherapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neoadjuvant endocrine therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Radiation Therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Chest Wall and Nodes', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Chest Wall alone', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Missing due to study withdrawal', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.'}, {'title': 'Technique', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'IMRT', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': '3D-Conformal', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Number analyzed differs from overall number due to participant withdrawals or participants found to be ineligible.'}, {'title': 'Time from surgery to RT (months) (Median, Q1, Q3)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG000', 'lowerLimit': '1.8', 'upperLimit': '5.3'}, {'value': '2.4', 'groupId': 'BG001', 'lowerLimit': '1.8', 'upperLimit': '4.9'}, {'value': '2.5', 'groupId': 'BG002', 'lowerLimit': '1.8', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-04', 'size': 1649135, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-03T13:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2030-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2018-01-19', 'resultsFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-28', 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Reported Outcomes Using the FACT-B', 'timeFrame': '6 months', 'description': 'The primary outcome is the change at 6 months from baseline in patient-reported outcomes on the Physical Well Being (PWB) sub-domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument. The FACT-B is a 37-item instrument designed to measure five domains of health-related quality of life in breast cancer patients. The higher the score, the better the quality of life.\n\nScore ranges:\n\n* The score range for the FACT-B total score is 0-148.\n* The score range for the PWB, social/family well-being (SWB), and functional well-being (FWB) subscales is 0-28.\n* The score range for the emotional well-being (EWB) subscale is 0-24.\n* The score range for the breast cancer subscale (BCS) is 0-40.'}], 'secondaryOutcomes': [{'measure': 'Oncologic and Clinical Outcomes Assessed Using Medical Record Abstractions.', 'timeFrame': '10 years', 'description': 'Clinical and oncologic outcomes (rare radiation side effects, recurrence, infections, additional surgeries) will be assessed over a period of 10 years through annual medical record abstractions.'}, {'measure': 'Cosmetic Outcomes Assessed Using Photographic Evaluations.', 'timeFrame': '18 months', 'description': 'Cosmetic outcomes (quality of reconstructive surgery throughout and after radiation therapy) will be assessed from baseline to 18 months by trained physicians using a standardized rating scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Radiation', 'Hypofractionation', 'Randomization'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24656685', 'type': 'BACKGROUND', 'citation': "EBCTCG (Early Breast Cancer Trialists' Collaborative Group); McGale P, Taylor C, Correa C, Cutter D, Duane F, Ewertz M, Gray R, Mannu G, Peto R, Whelan T, Wang Y, Wang Z, Darby S. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Jun 21;383(9935):2127-35. doi: 10.1016/S0140-6736(14)60488-8. Epub 2014 Mar 19."}, {'pmid': '26021276', 'type': 'BACKGROUND', 'citation': 'Duxbury PJ, Gandhi A, Kirwan CC, Jain Y, Harvey JR. Current attitudes to breast reconstruction surgery for women at risk of post-mastectomy radiotherapy: A survey of UK breast surgeons. Breast. 2015 Aug;24(4):502-12. doi: 10.1016/j.breast.2015.05.002. Epub 2015 May 26.'}, {'pmid': '18356109', 'type': 'BACKGROUND', 'citation': "START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19."}, {'pmid': '26247543', 'type': 'BACKGROUND', 'citation': 'Shaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.'}, {'pmid': '25494006', 'type': 'BACKGROUND', 'citation': 'Bekelman JE, Sylwestrzak G, Barron J, Liu J, Epstein AJ, Freedman G, Malin J, Emanuel EJ. Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013. JAMA. 2014 Dec 17;312(23):2542-50. doi: 10.1001/jama.2014.16616.'}, {'pmid': '25539365', 'type': 'BACKGROUND', 'citation': 'Jagsi R, Falchook AD, Hendrix LH, Curry H, Chen RC. Adoption of hypofractionated radiation therapy for breast cancer after publication of randomized trials. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1001-9. doi: 10.1016/j.ijrobp.2014.09.032.'}, {'pmid': '39115975', 'type': 'DERIVED', 'citation': 'Wong JS, Uno H, Tramontano AC, Fisher L, Pellegrini CV, Abel GA, Burstein HJ, Chun YS, King TA, Schrag D, Winer E, Bellon JR, Cheney MD, Hardenbergh P, Ho A, Horst KC, Kim JN, Leonard KL, Moran MS, Park CC, Recht A, Soto DE, Shiloh RY, Stinson SF, Snyder KM, Taghian AG, Warren LE, Wright JL, Punglia RS. Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial. JAMA Oncol. 2024 Oct 1;10(10):1370-1378. doi: 10.1001/jamaoncol.2024.2652.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.', 'detailedDescription': 'Over 180,000 diagnoses of invasive breast cancer are made in the US each year. Over one-third of women with early stage and over half with late-stage breast cancer are treated with mastectomy (removal of the entire breast) due to tumor size, multiple cancers within the breast, genetic cancer predisposition, and/or patient preference. Following treatment with mastectomy, women who receive breast reconstructive surgery may experience better quality of life as they do not have to leave surgery with a bare chest wall. However, large randomized trials of post-mastectomy radiation therapy reveal a survival benefit with the addition of radiation after mastectomy in women who have cancer present in the axillary lymph nodes (6). The delivery of radiation therapy in the presence of a breast reconstruction is challenging and often leads to undesirable consequences including reconstruction loss, need for major surgical revision, or poor cosmetic outcomes. Therefore, oncologists and patients are forced to decide between the potential for improved oncologic outcomes with radiation therapy versus increased likelihood of complications and suboptimal cosmetic results. Because of this, some patients may be foregoing reconstruction if radiation therapy after mastectomy is needed; or foregoing radiation therapy if they have had breast reconstructive surgery (28).\n\nHypofractionation enhances patient convenience and decreases treatment burden. This regimen has been shown in randomized trials largely in the breast-conservation setting to reduce acute radiation therapy side-effects, decrease fatigue at six months and improve cosmetic results (21, 22). Despite these results, adoption of hypofractionation has been slow among women with breast cancer treated with breast-conserving surgery (24, 25) likely due to familiarity and experience of conventional long-course radiation therapy.\n\nWhile hypofractionation is used commonly in the UK for patients with mastectomy, there are no randomized studies particularly studying outcomes following shorter course radiation therapy in women who undergo mastectomy with breast reconstruction. Therefore, there is an even greater barrier to the use of hypofractionation in this setting in the US. With improved cosmetic results found with hypofractionation, this shorter regimen may have the potential to improve reconstruction success rates which are unfortunately modest overall, for patients who require post-mastectomy radiation. Especially in contrast to financial disincentives to reduce number of radiation treatments, Level I randomized evidence is needed in this population to change practice patterns regarding radiation regimen.\n\nOur study of radiation fractionation regimens has the potential to increase use of hypofractionation among women treated with mastectomy, thereby decreasing treatment burden. Our team of patient stakeholders ensures that our outcomes measures encompass all domains of survivorship after breast cancer (physical and mental health as well as satisfaction with the decision-making process). Despite the large numbers of breast cancer survivors who undergo mastectomy, reconstruction and radiation therapy, little is known about which domains of quality of life are affected and their importance to these patients. This study uses previously validated tools for measuring patient outcomes, and have added questions for areas which are important to patients that may not have been captured adequately by previous tools. In concert with the increasing awareness of the importance of survivorship care to cancer care, identifying a comprehensive set of outcomes measurement tools following treatment with radiation therapy, mastectomy, and reconstruction is an important asset for future treatment evaluation in these women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with clinical or pathologic stage I-III invasive breast cancer with TX-T3 tumor\n2. Has been treated with mastectomy\n3. Has undergone immediate reconstructive surgery with placement of a tissue expander or permanent implant at time of mastectomy\n4. Is a candidate for unilateral post-mastectomy radiation therapy as per National Comprehensive Cancer Network (NCCN) guidelines (post-mastectomy radiation therapy is indicated for most patients with positive lymph nodes at time of surgery and infrequently for selected node-negative patients)\n5. Use of bolus is permitted, but not required\n6. Age ≥18\n\nExclusion Criteria:\n\n1. T4 cancer\n2. Recurrent breast cancer or history of prior breast radiation therapy\n3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or mental health illness that the consenting investigator feels would affect patient's ability to participate in this study\n4. Pregnant or nursing\n5. History of a different malignancy except for the following circumstances:\n\n * Disease-free for at least five years and deemed by the investigator to be at low risk for recurrence of that malignancy (\\<5 %).\n * Cervical cancer in situ and basal cell or squamous cell carcinoma of the skin\n6. Breast cancer requiring bilateral breast/chest wall radiation therapy."}, 'identificationModule': {'nctId': 'NCT03422003', 'briefTitle': 'Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma', 'orgStudyIdInfo': {'id': '16-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Hypofractionation', 'description': '16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.', 'interventionNames': ['Radiation: Radiation Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Conventional Radiation Therapy', 'description': '25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'description': 'For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.\n\nFor the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.', 'armGroupLabels': ['Arm 1: Hypofractionation', 'Arm 2: Conventional Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '81632', 'city': 'Edwards', 'state': 'Colorado', 'country': 'United States', 'facility': 'Vail Health', 'geoPoint': {'lat': 39.64499, 'lon': -106.5942}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '04412', 'city': 'Brewer', 'state': 'Maine', 'country': 'United States', 'facility': 'Eastern Maine Medical Center', 'geoPoint': {'lat': 44.79674, 'lon': -68.76142}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01923', 'city': 'Danvers', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital/North Shore Center for Outpatient Care', 'geoPoint': {'lat': 42.57509, 'lon': -70.93005}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center", 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'zip': '02190', 'city': 'South Weymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital", 'geoPoint': {'lat': 42.1751, 'lon': -70.94949}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lifespan/Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rinaa Punglia, MD MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Dana-Farber Cancer Institute'}, {'name': 'Julia Wong, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Rinaa Punglia, MD, MPH', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}