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ClinicalTrials.gov NCT01730833, versions 25-26. 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 25 to version 26 for NCT01730833.","The JSON Patch for this comparison has hash 89e4319596c5a24e20681cfd52ca6606254856203cf87162b377c7e74461f874.","The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.","The deterministic triage label was high; before timing 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Nab-paclitaxel 100 mg/m2 IV weekly.

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Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

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Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"BG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"31","upperLimit":"65","value":"49"},{"groupId":"BG001","lowerLimit":"31","upperLimit":"78","value":"56"},{"groupId":"BG002","lowerLimit":"31","upperLimit":"78","value":"54"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"63"}],"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":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}],"title":"African American"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"9"}]}],"title":"Asian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"29"}]}],"title":"Hispanic"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"22"}]}],"title":"Non-Hispanic White"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Unknown"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"63"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"email":"pfrankel@coh.org","organization":"City of Hope","phone":"626-218-5265","title":"Paul Frankel, Ph.D."}},"outcomeMeasuresModule":{"outcomeMeasures":[{"classes":[{"categories":[{"measurements":[{"comment":"NA - The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.","groupId":"OG000","lowerLimit":"7.1","upperLimit":"NA","value":"22.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Estimated using the product-limit method of Kaplan and Meier.\nFrom time of initial treatment until disease progression or death.\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG000","title":"Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients"},{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"}],"paramType":"MEDIAN","populationDescription":"PFS was not performed on the LABC cohort (neoadjuvant patients).\nA more relevant analysis, Disease-free survival is present elsewhere in these results.","reportingStatus":"POSTED","timeFrame":"assessed up to 5 years","title":"Progression Free Survival (MBC Cohort)","type":"PRIMARY","unitOfMeasure":"Months"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"76.5","upperLimit":"99.5","value":"96.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"29"}],"units":"Participants"}],"description":"Estimated using the method of Kaplan-Meier.\nDisease-free survival is defined as the time from Initial treatment to recurrence of tumor or death","dispersionType":"95% Confidence Interval","groups":[{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG000","title":"Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients"},{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"}],"paramType":"NUMBER","populationDescription":"Analysis population included LABC participants who achieved pathologic response (pCR).\nMore appropriate PFS analysis for MBC cohort is presented elsewhere in these results.","reportingStatus":"POSTED","timeFrame":"assessed up to 5 years","title":"Five Year Disease-free Survival (LABC Cohort)","type":"PRIMARY","unitOfMeasure":"percentage of participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR","groups":[{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG000","title":"Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients"},{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Overall response is not appropriate in the neoadjuvant or LABC cohort.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Overall Response (MBC Cohort)","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.6","upperLimit":"86.1","value":"54.5"},{"groupId":"OG001","lowerLimit":"77.6","upperLimit":"98.5","value":"94.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"description":"Estimated by the Kaplan-Meier method.\nFrom the initial date of treatment to date of death from any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG000","title":"Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients"},{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"OG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Assessed up to 5 years","title":"Five Year Overall Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}]},"participantFlowModule":{"groups":[{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

Disease progression Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"FG000","title":"Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients"},{"description":"

Pertuzumab administered as 840 mg IV during cycle 1 followed by 420 mg IV once every three weeks starting cycle 2.

Trastuzumab loading dose of 4mg/kg IV for week one followed by 2mg/kg IV weekly.

Nab-paclitaxel 100 mg/m2 IV weekly.

Treatment is scheduled to continue until:

A planned 6 cycles Unmanageable toxicity Primary physician or patient request to discontinue therapy Study termination by the sponsors

","id":"FG001","title":"Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"45"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"45"}],"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":"2017-07-27","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":1340713,"typeAbbrev":"Prot_SAP","uploadDate":"2023-04-05T18:58"}]}}}],"provenance":{"from_snapshot_hash":"b74489640d817b4ccc2101206931c46dae3ee41fa007dd65d067826bf331b85f","materiality_event_hash":"48e1c2466f23e52c05406bc6bdbc55493e3df60e0c28ac2e7fa01f6859e67384","patch_hash":"89e4319596c5a24e20681cfd52ca6606254856203cf87162b377c7e74461f874","patch_raw_hash":"c14a90f0d19d83059e60de30678fa907e948aa01d5f8b1a5bcc7f19d3dde3b2f","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT01730833/history/25?patchToVersion=26","to_snapshot_hash":"4f198e7323dd5b03496d2c769b17d3150bf9f69ddc05acd986210360db22fc0f"},"review_question":"What explains the enrollment change, and does the change affect interpretation of trial feasibility or power?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT01730833","nct_id":"NCT01730833"},"versions":{"from_version":25,"submitted_date":"2023-06-26","to_version":26}}