{"changed_paths":["/protocolSection/statusModule/statusVerifiedDate","/protocolSection/statusModule/lastUpdateSubmitDate","/protocolSection/statusModule/lastUpdatePostDateStruct/date","/protocolSection/statusModule/resultsFirstSubmitDate","/protocolSection/statusModule/resultsFirstSubmitQcDate","/protocolSection/statusModule/resultsFirstPostDateStruct","/protocolSection/outcomesModule/primaryOutcomes/0/measure","/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/measure","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/1/measure","/protocolSection/outcomesModule/secondaryOutcomes/1/description","/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/2/measure","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","/hasResults","/resultsSection","/documentSection"],"citation_text":"TrialDiff Evidence Record evt_NCT03535506_v8_v9_3f1754c7a693. ClinicalTrials.gov NCT03535506, versions 8-9. Evidence version 1.","claims_not_supported":["That the amendment was scientifically unjustified.","That the change constitutes misconduct or wrongdoing.","That sponsor intent can be inferred from this registry change.","That the change caused or altered the trial's results.","That the change was or was not disclosed in a manuscript.","That TrialDiff determines regulatory compliance or non-compliance.","That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.","That event-class membership is a validated global review-priority ranking."],"claims_supported":["TrialDiff compared ClinicalTrials.gov record version 8 to version 9 for NCT03535506.","The JSON Patch for this comparison has hash b0b377c7df2d5c4c0e57a1fba4d88d08e73ed3a2bdfce18162f0ef3ae67c46f2.","The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.","The deterministic triage label was low; before timing adjustment it was low.","The triage label is uncalibrated metadata, not a validated review-priority finding.","The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.","The timing context for the from-version record was post_recruitment.","The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes/0/description, /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/1/measure, /protocolSection/outcomesModule/secondaryOutcomes/1/description, /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/2/measure, /protocolSection/outcomesModule/secondaryOutcomes/2/description, /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame, /hasResults, /resultsSection, /documentSection.","An outcome path changed between versions 8 and 9 in a patch that also carried a hasResults or resultsSection co-occurrence signal."],"classification":{"calibration_status":"uncalibrated","categories":["results_reconciliation"],"category":"results_reconciliation","deterministic_rules":[],"event_class_rule_set_hash":"74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c","event_classes":["outcome_edit_cooccurs_with_results_posting"],"rule_set_hash":"fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621","severity":"low","severity_pre_timing":"low","timing_context":"post_recruitment","triage_label":"low","triage_rule_set_hash":"af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b","value_signals":[{"category":"results_reconciliation","paths":["/protocolSection/outcomesModule/primaryOutcomes/0/description","/protocolSection/outcomesModule/primaryOutcomes/0/measure","/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/0/description","/protocolSection/outcomesModule/secondaryOutcomes/0/measure","/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/1/description","/protocolSection/outcomesModule/secondaryOutcomes/1/measure","/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","/protocolSection/outcomesModule/secondaryOutcomes/2/description","/protocolSection/outcomesModule/secondaryOutcomes/2/measure","/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame"],"severity":"low","signal":"results_reconciliation_outcome_suppression"}]},"event_id":"evt_NCT03535506_v8_v9_3f1754c7a693","evidence_version":1,"patch":[{"op":"replace","path":"/protocolSection/statusModule/statusVerifiedDate","value":"2025-09"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdateSubmitDate","value":"2025-09-08"},{"op":"replace","path":"/protocolSection/statusModule/lastUpdatePostDateStruct/date","value":"2025-09-26"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitDate","value":"2025-09-08"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstSubmitQcDate","value":"2025-09-08"},{"op":"add","path":"/protocolSection/statusModule/resultsFirstPostDateStruct","value":{"date":"2025-09-26","type":"ACTUAL"}},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/measure","value":"Feasibility: Recruitment Rates"},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/description","value":"The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study."},{"op":"replace","path":"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame","value":"5 years"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/measure","value":"Pathologic Changes"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/description","value":"Number of patients with pathologic changes in breast tissue before and after definitive surgery."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame","value":"2 months"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/measure","value":"Pathology Changes on Immunohistochemistry (IHC)"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/description","value":"Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame","value":"2 months"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/measure","value":"Toxcity Based on CTCAE"},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/description","value":"Number of subjects with an adverse event reported from time of consent until up to 32 days after surgery."},{"op":"replace","path":"/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame","value":"3 months"},{"op":"replace","path":"/hasResults","value":true},{"op":"add","path":"/resultsSection","value":{"adverseEventsModule":{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"Group A- Palbociclib Before Surgery"},{"deathsNumAffected":0,"deathsNumAtRisk":12,"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":12,"seriousNumAffected":0,"seriousNumAtRisk":12,"title":"Group B- No Pre-operative Treatment"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Dry Lips","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Gastrointestinal disorders - Other, specify:"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Covid-19","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Infections and infestations - Other, specify:"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":12,"numEvents":0}],"term":"Breast pain"}],"timeFrame":"3 months"},"baselineCharacteristicsModule":{"denoms":[{"counts":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"17"}],"units":"Participants"}],"groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"BG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"BG001","title":"Group B- No Pre-operative Treatment"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"14"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"17"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"15"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"8"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"email":"ns1209@georgetown.edu","organization":"Georgetown University","phone":"2026879194","title":"Nicole Swanson"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"description":"The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.","groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"OG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"OG001","title":"Group B- No Pre-operative Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Study was terminated due to lack of accural","reportingStatus":"POSTED","timeFrame":"5 years","title":"Feasibility: Recruitment Rates","type":"PRIMARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Number of patients with pathologic changes in breast tissue before and after definitive surgery.","groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"OG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"OG001","title":"Group B- No Pre-operative Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Subject in group B did not have specimens collected per protocol so was not included in the analysis.\nSubject in Group A could not be analyzed due to no evidence of disease at the time of definitive surgery.","reportingStatus":"POSTED","timeFrame":"2 months","title":"Pathologic Changes","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Number of treated subjects with pharmacodynamic changes evaluated by IHC from diagnostic biopsy to definitive surgery.","groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"OG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"OG001","title":"Group B- No Pre-operative Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Treatment arm evaluated for Changes and 1 participant had no evidence of disease at surgery so there was no surgical specimen available to evaluate.","reportingStatus":"POSTED","timeFrame":"2 months","title":"Pathology Changes on Immunohistochemistry (IHC)","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"description":"Number of subjects with an adverse event reported from time of consent until up to 32 days after surgery.","groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"OG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"OG001","title":"Group B- No Pre-operative Treatment"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"3 months","title":"Toxcity Based on CTCAE","type":"SECONDARY","unitOfMeasure":"Participants"}]},"participantFlowModule":{"groups":[{"description":"Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery.\nPatients will receive Palbociclib 100mg PO daily x 12 days.","id":"FG000","title":"Group A- Palbociclib Before Surgery"},{"description":"These patients will receive no pre-operative treatment.\nCore biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking.\nThey will also provide blood samples at screening and prior to definitive surgery.","id":"FG001","title":"Group B- No Pre-operative Treatment"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"12"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2022-01-20","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":5184266,"typeAbbrev":"Prot_SAP","uploadDate":"2025-05-22T09:52"}]}}}],"provenance":{"from_snapshot_hash":"67422727053382d95fa2f78922db75303597cc2bd92759b48ca7ada1c73dfe0d","materiality_event_hash":"46156cd346cd255dcae87b897f19018ffbb53cae6d9f74ffdff18db800e7a1b7","patch_hash":"b0b377c7df2d5c4c0e57a1fba4d88d08e73ed3a2bdfce18162f0ef3ae67c46f2","patch_raw_hash":"9d86a3310d1c15f486fee1c034386f3770615a4c8c1011d7c5bfe8e2ae273dbe","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT03535506/history/8?patchToVersion=9","to_snapshot_hash":null},"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/NCT03535506","nct_id":"NCT03535506"},"versions":{"from_version":8,"submitted_date":"2025-09-08","to_version":9}}