Primary endpoint number 1 : DLT analysis.
DLT analysis (one of the two primary endpoints) was conducted only on the 6 first patients of Arm A (Pembrolizumab Arm, 6 first patients out of the 33 included in Arm A. Zero patient out of the 19 patients included in Arm B were included in DLT analysis.)
"},{"op":"add","path":"/resultsSection/participantFlowModule/recruitmentDetails","value":"33 patients were assigned to Arm A. 19 patients were assigned to Arm B."},{"op":"replace","path":"/resultsSection/baselineCharacteristicsModule/populationDescription","value":"The DLT analysis was limited to the 6 first patients of Arm A (the 6 first patients out of the 33 included in Arm A. Zero patient out of the 19 patients included in Arm B were included in DLT analysis)."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/title","value":"Central Evaluation of Pathological Complete Response (pCR)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reportingStatus","value":"POSTED"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/anticipatedPostingDate"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame","value":"after mastectomy and axillary lymph node dissection, if applicable"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denomUnitsSelected"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/type","value":"SECONDARY"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/title","value":"Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description","value":"according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/paramType"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/denoms/0/counts/0/value","value":"0"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/classes"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/measureCategoriesReviewUnit/resetReasons/0","value":"Results information appears incomplete."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/anticipatedPostingDate","value":"2027-08"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title","value":"Local Evaluation of Pathological Complete Response Rate"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description","value":"defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus","value":"POSTED"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/anticipatedPostingDate"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame","value":"Following completion of neoadjuvant systemic treatment, an average of 24 weeks"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/title","value":"Invasive Disease-free Survival (IDFS)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description","value":"time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame","value":"3 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection
Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks
neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone
neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame","value":"5 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection
Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks
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","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone
neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/title","value":"Event Free Survival (EFS)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description","value":"time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame","value":"3 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame","value":"5 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/title","value":"Overall Survival (OS)"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description","value":"time from randomization to death from any cause"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame","value":"3 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame","value":"5 years"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/type","value":"OTHER_PRE_SPECIFIED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/title","value":"Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/description","value":"by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reportingStatus","value":"POSTED"},{"op":"replace","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame","value":"Following completion of neoadjuvant systemic treatment, an average of 24 weeks"},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denomUnitsSelected"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/populationDescription","value":"No participants were measured and analyzed for this Outcome Measure, due to statistical reasons (measure is excluded beacause the data does not meet statistical criteria)."},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups","value":[{"description":"EC Paclitaxel + Pembrolizumab Injection","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/denoms","value":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/measureCategoriesReviewUnit","value":{"resetReasons":["Results information appears incomplete."]}},{"op":"remove","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/10"},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/13","value":{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-).\nDLTs will be defined according to CTCAE.","groups":[{"description":"EC Paclitaxel + Pembrolizumab Injection
Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks
neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
","id":"OG000","title":"Pembrolizumab"},{"description":"EC Paclitaxel alone
neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
","id":"OG001","title":"Standard Neoadjuvant Chemotherapy"}],"measureCategoriesReviewUnit":{"resetReasons":["Required information appears to be missing."]},"paramType":"NUMBER","populationDescription":"only pembrolizumab patients have been analyzed for DLT","reportingStatus":"POSTED","timeFrame":"during 21 days following the first administration of pembrolizumab","title":"Dose Limiting Toxicity (DLT) Rates","type":"PRIMARY","unitOfMeasure":"patients"}},{"op":"replace","path":"/resultsSection/adverseEventsModule/timeFrame","value":"through 30 days after the last dose of study treatment or before the initiation of radiotherapy, whichever comes first. All AEs that occured prior to the Safety Follow-Up Visit were recorded. Patients with an AE of Grade > 1 were followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-cancer therapy (excluding the scheduled post-mastectomy treatments), whichever occured first."},{"op":"replace","path":"/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date","value":"2025-12-01"},{"op":"add","path":"/reviewUnit","value":{"resetReasons":["Issues noted on a previous submission of this record do not appear to have been addressed."]}}],"provenance":{"from_snapshot_hash":"1de15830c019be6f995684a37d65aeda5e05f73a7954f6d54c31aa596fd07fb2","materiality_event_hash":"816f274f98aa3adea963176b1f419586e80ffe04d71721f82ee07bb7d59d4aa4","patch_hash":"3b8ac6cb69a604f3bd69649d68d4f1777c68c9280aca25a98881388e80dc48ce","patch_raw_hash":"02bae03185f54a4d11a92fd949178eca723f68ff723c9db503bcacb005ab9a56","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT03515798/history/6?patchToVersion=7","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/NCT03515798","nct_id":"NCT03515798"},"versions":{"from_version":6,"submitted_date":"2025-11-17","to_version":7}}