Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.>>\n>> therapeutic conventional surgery>>
>> whole breast irradiation
","id":"BG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"40","upperLimit":"87","value":"60.5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"270"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"245"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"16"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"22"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"232"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"email":"Boughey.Judy@mayo.edu","organization":"Mayo Clinic","phone":"507-266-9997","title":"Judy Boughey"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.3","upperLimit":"6.4","value":"3.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"204"}],"units":"Participants"}],"description":"Local recurrence(LR) defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years.\nThe estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.","id":"OG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"paramType":"NUMBER","populationDescription":"All patients that received protocol therapy and were evaluated for response","reportingStatus":"POSTED","timeFrame":"5 years","title":"Local Recurrence","type":"PRIMARY","unitOfMeasure":"percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"198"}],"units":"Participants"}],"description":"The conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting BCS; or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.","groups":[{"description":"Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.>\n>>
>
>> therapeutic conventional surgery>
>>
>
>> whole breast irradiation
","id":"OG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"paramType":"NUMBER","populationDescription":"There are only 198 patients in this analysis because it excludes those registered postoperatively","reportingStatus":"POSTED","timeFrame":"5 years","title":"Conversion Rate to Mastectomy","type":"SECONDARY","unitOfMeasure":"percentage of patients converted"},{"denomUnitsSelected":"Participants","reportingStatus":"NOT_POSTED","timeFrame":"Up to 30 days post-treatment","title":"Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0","type":"SECONDARY"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"74"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Grade 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"}],"units":"Participants"}],"description":"Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0.","groups":[{"description":"Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.","id":"OG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All eligible patients that received radiation therapy.","reportingStatus":"POSTED","timeFrame":"17 months","title":"Radiation-related Side Effects","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70.6"}]}],"title":"Good or excellent (50-100)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25.7"}]}],"title":"Fair (25-50)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.7"}]}],"title":"Poor (0-25)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"216"}],"units":"Participants"}],"description":"Patient's perception of cosmesis will be assessed at their initial post-operative visit as well as 24 months following completion of WBI using the BREAST-Q subscales: satisfaction with breasts, satisfaction with overall outcome, and physical well-being.\nPatients registered after surgery will not partake in the pre-operative assessment but will be asked to complete subsequent cosmesis surveys.\nThe total score for each of these subscales will be determined using the BREAST-Q scoring module (http://www.mskcc.org/mskcc/shared/Breast-Q/scoreBQ.html).\nThe BREAST-Q has multiple domains, and each domain score is obtained by transforming the raw scale item responses with the Q-Score software program.\nEach domain results in an independent score from 0 to 100 (higher scores indicate greater satisfaction or quality of life).","groups":[{"description":"Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.","id":"OG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"24 months","title":"Patient's Perception of Cosmesis","type":"SECONDARY","unitOfMeasure":"percentage of patients"}]},"participantFlowModule":{"groups":[{"description":"Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy.>>\n>> therapeutic conventional surgery>>
>> whole breast irradiation
","id":"FG000","title":"Breast Conservation Surgery and Radiation Therapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"34"}],"type":"Ineligible"},{"reasons":[{"groupId":"FG000","numSubjects":"14"}],"type":"Converted to mastectomy"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Unable to achieve negative margins"},{"reasons":[{"groupId":"FG000","numSubjects":"16"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"270"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"204"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"66"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2018-09-11","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":1148412,"typeAbbrev":"Prot_SAP","uploadDate":"2023-06-15T15:04"}]}}}],"provenance":{"from_snapshot_hash":"ac22baf19f87b8d896843f36c96caa6f9b0e6e8316722ca56a29dc67f073bf9b","materiality_event_hash":"9b8059334b4073ab716b238f2a8cc04b5fe2656d2b0ec2baad529b9a2bdf8347","patch_hash":"1fde7c8e9a36df4472a434d69d48134a0e86c0c0f25a9740db75769967b7ccd3","patch_raw_hash":"2604036b4559c4385f8c1c68cbd361bc75321378b92167f9d8f3988bb64b2e20","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT01556243/history/28?patchToVersion=29","to_snapshot_hash":"6d36d1a617e03c4a0a05c407b4410c171c8868068b11b70bea2c26964a242f92"},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT01556243","nct_id":"NCT01556243"},"versions":{"from_version":28,"submitted_date":"2023-11-07","to_version":29}}