Evidence Record
evt_NCT04578106_v3_v4_f8f0a387a1c0
NCT04578106 · Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT04578106_v3_v4_2d705b7ef592.
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. This page states what the registry evidence supports and what it does not support.
Triage severity
Triage: High Category
Status Termination
Versions
v3 to v4
Timing
Early Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 3 to version 4 for NCT04578106.
- The JSON Patch for this comparison has hash 9c1dfc8c1bd85d5723205c9461e8f3a6553c816ba10f133c26b6838bd95f7c34.
- The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.
- The deterministic triage label was high; before timing adjustment it was high.
- 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.
- A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 3 and 4.
- The timing context for the from-version record was early_recruitment.
- The deterministic rules that fired were: contact_admin_change, enrollment_count_change, enrollment_type_change, terminal_status_change, why_stopped_change.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes, /protocolSection/contactsLocationsModule/centralContacts, /protocolSection/contactsLocationsModule/locations/0/status, /protocolSection/contactsLocationsModule/locations/0/contacts, /protocolSection/contactsLocationsModule/locations/0/state, /annotationSection, /hasResults, /resultsSection, /documentSection.
- The timeline value moved by 868 days.
- The enrollment count changed by at least 20 percent.
- An outcome path changed between versions 3 and 4 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
- The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable.
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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.
- 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.
Neutral Review Question
Does the public registry record give a specific explanation for the stopped or terminal status?
Citation
TrialDiff Evidence Record evt_NCT04578106_v3_v4_f8f0a387a1c0. ClinicalTrials.gov NCT04578106, versions 3-4. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/overallStatus
/protocolSection/statusModule/primaryCompletionDateStruct/date
/protocolSection/statusModule/primaryCompletionDateStruct/type
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/whyStopped
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/secondaryOutcomes
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/state
/annotationSection
/hasResults
/resultsSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
contact_admin_changeenrollment_count_changeenrollment_type_changeterminal_status_changewhy_stopped_change Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT04578106_v3_v4_2d705b7ef592
- Patch hash
9c1dfc8c1bd85d5723205c9461e8f3a6553c816ba10f133c26b6838bd95f7c34- Canonical hash
34adad9b496d6b80b77ec136233a4deb4bcafc1b90309206d5ba7c83c0ab2449- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
5e985270d681649633bafe0f41747fc0682a970faef0b062f57856ef13c7124e- To snapshot
Unavailable- Patch source
- ctgov_internal_history
- Generated at
- 2026-07-31T00:42:12.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/overallStatus",
"/protocolSection/statusModule/primaryCompletionDateStruct/date",
"/protocolSection/statusModule/primaryCompletionDateStruct/type",
"/protocolSection/statusModule/completionDateStruct/date",
"/protocolSection/statusModule/completionDateStruct/type",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/whyStopped",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/designModule/enrollmentInfo/type",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes",
"/protocolSection/contactsLocationsModule/centralContacts",
"/protocolSection/contactsLocationsModule/locations/0/status",
"/protocolSection/contactsLocationsModule/locations/0/contacts",
"/protocolSection/contactsLocationsModule/locations/0/state",
"/annotationSection",
"/hasResults",
"/resultsSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT04578106_v3_v4_f8f0a387a1c0. ClinicalTrials.gov NCT04578106, versions 3-4. 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 TrialDiff determines whether the stopped-trial explanation satisfies 42 CFR 11.64.",
"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 3 to version 4 for NCT04578106.",
"The JSON Patch for this comparison has hash 9c1dfc8c1bd85d5723205c9461e8f3a6553c816ba10f133c26b6838bd95f7c34.",
"The active deterministic rule set hash was 318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86.",
"The deterministic triage label was high; before timing adjustment it was high.",
"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.",
"A registry field under the status or stopped-trial explanation module changed between ClinicalTrials.gov versions 3 and 4.",
"The timing context for the from-version record was early_recruitment.",
"The deterministic rules that fired were: contact_admin_change, enrollment_count_change, enrollment_type_change, terminal_status_change, why_stopped_change.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/overallStatus, /protocolSection/statusModule/primaryCompletionDateStruct/date, /protocolSection/statusModule/primaryCompletionDateStruct/type, /protocolSection/statusModule/completionDateStruct/date, /protocolSection/statusModule/completionDateStruct/type, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/whyStopped, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/secondaryOutcomes, /protocolSection/contactsLocationsModule/centralContacts, /protocolSection/contactsLocationsModule/locations/0/status, /protocolSection/contactsLocationsModule/locations/0/contacts, /protocolSection/contactsLocationsModule/locations/0/state, /annotationSection, /hasResults, /resultsSection, /documentSection.",
"The timeline value moved by 868 days.",
"The enrollment count changed by at least 20 percent.",
"An outcome path changed between versions 3 and 4 in a patch that also carried a hasResults or resultsSection co-occurrence signal.",
"The changed paths include the ClinicalTrials.gov whyStopped field, a stopped-trial explanation field relevant to 42 CFR 11.64 when applicable."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"status_termination",
"enrollment_change",
"timeline_actualized_earlier",
"administrative_contact_change",
"results_reconciliation"
],
"category": "status_termination",
"deterministic_rules": [
"contact_admin_change",
"enrollment_count_change",
"enrollment_type_change",
"terminal_status_change",
"why_stopped_change"
],
"event_class_rule_set_hash": "07957f8b90549d4f42387f51b471ecde9901b6db63bbc27b84c73631603407c0",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "early_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "timeline_actualized_earlier",
"date_struct": "primaryCompletionDateStruct",
"delta_days": 868,
"direction": "earlier",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2024-07-16",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2026-12",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "timeline_actualized_earlier",
"date_struct": "completionDateStruct",
"delta_days": 868,
"direction": "earlier",
"new_precision": "day",
"new_type": "ACTUAL",
"new_value": "2024-07-16",
"old_precision": "month",
"old_type": "ESTIMATED",
"old_value": "2026-12",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"severity": "low",
"signal": "timeline_actualized_earlier"
},
{
"category": "enrollment_change",
"new_value": 5,
"old_value": 17,
"path": "/protocolSection/designModule/enrollmentInfo/count",
"pct_change": 0.7059,
"severity": "high",
"signal": "enrollment_count_change_ge_20pct"
},
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/measure"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT04578106_v3_v4_f8f0a387a1c0",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2026-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "TERMINATED"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2024-07-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/date",
"value": "2024-07-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/completionDateStruct/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2026-01-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2026-01-06"
},
{
"op": "add",
"path": "/protocolSection/statusModule/whyStopped",
"value": "The study was prematurely halted primarily due to low patient accrual.\nDespite efforts to optimize recruitment, the enrollment rate remained insufficient to meet the predefined targets, and continuation was deemed unfeasible"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-09-05"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2026-01-02"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2026-01-06",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 5
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Disease-free Survival at 3years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes",
"value": [
{
"description": "rate of pathological complete response (pCR) between the treatment groups by HR status",
"measure": "pCR Rate",
"timeFrame": "pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy"
},
{
"description": "<p>The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.</p><p>The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).</p><p>Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7</p>",
"measure": "Patient Reported Outcomes (Global Health Status)",
"timeFrame": "The questionnaire was filled by the patients at screening and post adjuvant therapy."
}
]
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/centralContacts"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0/status"
},
{
"op": "remove",
"path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/state",
"value": "Barcelona"
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"id": "EG000",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 0,
"seriousNumAtRisk": 5,
"title": "Treatment Arm (Treatment With Paclitaxel)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"id": "EG001",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 0,
"seriousNumAtRisk": 5,
"title": "Treatment Arm (Treatment With Trastuzumab)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 5,
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"id": "EG002",
"otherNumAffected": 5,
"otherNumAtRisk": 5,
"seriousNumAffected": 0,
"seriousNumAtRisk": 5,
"title": "Treatment Arm (Treatment With Pertuzumab)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 3,
"description": "TDM-1 administered on Day 1 of a 3-week cycle q3w at a doce of 3.6 mg/kg IV as adjuvant treatment in patients of the treatment population with non-complete response in the neoadjuvant setting",
"id": "EG003",
"otherNumAffected": 3,
"otherNumAtRisk": 3,
"seriousNumAffected": 0,
"seriousNumAtRisk": 3,
"title": "Treatment Arm (Adjuvant Treatment With TDM1)"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 5,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "alopecia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 3
}
],
"term": "asthenia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "dysguesia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 5,
"numEvents": 2
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 5,
"numEvents": 4
},
{
"groupId": "EG002",
"numAffected": 4,
"numAtRisk": 5,
"numEvents": 4
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "erythema face and hands"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 5,
"numEvents": 3
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "erythema arms and hands"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "feet erythema"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "hands neurotoxicity"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 1
}
],
"term": "hiporexya"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "mucositis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "neurotoxicity in foot"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "occasional epistaxis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "onychodystrophy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "onycholysis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "plantar erythema"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "cough"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "erythematous reaction"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG002",
"numAffected": 1,
"numAtRisk": 5,
"numEvents": 1
},
{
"groupId": "EG003",
"numAffected": 0,
"numAtRisk": 3,
"numEvents": 0
}
],
"term": "muscle pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 2
}
],
"term": "plaquetopenia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 1
}
],
"term": "decrease in hemoglobin"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 1,
"numAtRisk": 3,
"numEvents": 1
}
],
"term": "increase of total bilirubine"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 3,
"numAtRisk": 3,
"numEvents": 4
}
],
"term": "alat increase"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 2,
"numAtRisk": 3,
"numEvents": 2
}
],
"term": "asat increase"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 2,
"numAtRisk": 3,
"numEvents": 2
}
],
"term": "epigastralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE (5)",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG002",
"numAffected": 0,
"numAtRisk": 5,
"numEvents": 0
},
{
"groupId": "EG003",
"numAffected": 2,
"numAtRisk": 3,
"numEvents": 2
}
],
"term": "increase of alkaline phosphatase"
}
],
"timeFrame": "Study treatment duration - 1 year (neoadjuvant and adjuvant therapy)"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "5"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"id": "BG000",
"title": "Treatment Arm"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
}
]
}
],
"title": ">= 40 yrs"
}
],
"paramType": "NUMBER",
"title": "Age, Customized",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
}
],
"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": "5"
}
]
}
],
"title": "Caucasian"
}
],
"paramType": "NUMBER",
"title": "Race/Ethnicity, Customized",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
}
]
}
],
"title": "Spain"
}
],
"paramType": "NUMBER",
"title": "Region of Enrollment",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
}
]
}
],
"title": "Postmenopausal (min 12 mnths without menses before neoadyuvance treatment)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
}
]
}
],
"title": "premenopausal"
}
],
"paramType": "NUMBER",
"title": "Menopausal Status",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "4"
}
]
}
],
"title": "Grade 0"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
}
]
}
],
"title": "Grade 1"
}
],
"description": "Scale: Grades 0-4 Grade 0 - Fully active able to carry on all pre-disease performance without restriction; Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g.\nlight house work office work; Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair",
"paramType": "NUMBER",
"title": "ECOG baseline",
"unitOfMeasure": "participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
]
}
],
"title": "Yes"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
}
]
}
],
"title": "No"
}
],
"paramType": "NUMBER",
"title": "Previous cancer history",
"unitOfMeasure": "participants"
}
],
"populationDescription": "The baseline analysis population is the same as the treatment population"
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": true
},
"pointOfContact": {
"email": "topascual@clinic.cat",
"organization": "Hospital Clínic de Barcelona",
"phone": "932275400",
"title": "Dr. Tomas Pascual"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "0"
}
],
"units": "Participants"
}
],
"description": "To estimate the loco-regional invasive disease-free survival (LR-IDFS) at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "After completion of neoadjuvant therapy, if no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB (complete response), patients will be eligible to omit loco-regional surgery",
"id": "OG000",
"title": "Omision of Surgery (Complete Response)"
}
],
"paramType": "MEDIAN",
"populationDescription": "After completion of neoadjuvant therapy with paclitaxel and Trastuzumab/pertuzumab, out of 5 patients, only 3 patients showed complete response (assessed by MRI) and 2 patients (no stereo-guided VAB assessment) did not undergo surgery.\nHowever, the participants were lost to follow-up before 3-year assessments, so no evaluable 3-year survival data are available",
"reportingStatus": "POSTED",
"timeFrame": "3 years",
"title": "Disease-free Survival at 3years",
"type": "PRIMARY",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "2"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "2"
}
],
"units": "Participants"
}
],
"description": "rate of pathological complete response (pCR) between the treatment groups by HR status",
"groups": [
{
"description": "patients that are hormone receptor (HR) positive (assessment at baseline)",
"id": "OG000",
"title": "HR Positive"
},
{
"description": "Patients that are hormone receptor (HR) negative (assessed at baseline)",
"id": "OG001",
"title": "HR Negative"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "While total number of HR positive patients and HR negative patients in the overall treatment group is 2 and 3 respectively, only 1 patient in the former and 2 patients in the later group were evaluated for pCR at surgery",
"reportingStatus": "POSTED",
"timeFrame": "pCR assessment was done following surgery after neoadjuvant therapy with paclitaxel and trastuzumzb/pertuzumab prior to adjuvant therapy",
"title": "pCR Rate",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "5",
"upperLimit": "6",
"value": "5"
},
{
"groupId": "OG001",
"lowerLimit": "3.5",
"upperLimit": "4.5",
"value": "4"
},
{
"groupId": "OG002",
"lowerLimit": "4.5",
"upperLimit": "6",
"value": "5.25"
},
{
"groupId": "OG003",
"lowerLimit": "4",
"upperLimit": "6",
"value": "5"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "2"
},
{
"groupId": "OG002",
"value": "2"
},
{
"groupId": "OG003",
"value": "2"
}
],
"units": "Participants"
}
],
"description": "<p>The EORTC QLQ-C30 was used to assess Health-Related Quality of Life (QoL).\nThe measure consists of five functional scales (physical, role, cognitive, emotional, and social).\nFor this study, raw scores were used without any transformation.\nThe functional scales consist of multiple items (questions 1-28) scored on a 1-4 scale (1 = not at all, 4 = very much).\nHigher scores indicate worse functioning.\nTo assess the effect of standard therapy (surgery after neoadjuvant therapy) vs. investigational therapy (omission of surgery), the global health status is reported in each of these populations before and after treatment.</p><p>The Global Health Status (GHS) score is derived from two items (Q29 and Q30), each scored on a 1-7 scale (1 = very poor, 7 = excellent).</p><p>Scoring method: GHS = (Q29 + Q30) / 2 Raw score range: Minimum = (1 + 1) / 2 = 1; Maximum = (7 + 7) /2 = 7</p>",
"dispersionType": "Full Range",
"groups": [
{
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is at screening</p>",
"id": "OG000",
"title": "Patients Who Underwent Surgery (Assessment at Screening)"
},
{
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is after adjuvant therapy</p>",
"id": "OG001",
"title": "Patients Who Underwent Surgery (Assessment After Adjuvant Therapy)"
},
{
"description": "<p>Of the treatment population, those patients with omission of surgery post neoadjuvant therapy.</p><p>The assessment time period is at screening</p>",
"id": "OG002",
"title": "Patients With Omission of Surgery (Assessment at Screening)"
},
{
"description": "<p>Of the treatment population, those patients who underwent surgery post neoadjuvant therapy.</p><p>The assessment time period is after adjuvant therapy</p>",
"id": "OG003",
"title": "Patients With Omission of Surgery (Assessment After Adjuvant Therapy)"
}
],
"paramType": "MEDIAN",
"populationDescription": "Out of the treatment population, 3 patients underwent surgery post neoadjuvant therapy (standard therapy) and 2 patients did not undergo surgery (investigative therapy).\nAll the patients of both the groups completed the patient reported outcomes questionaire at screening. 1 patient from the patient group that underwent surgery did not complete the questionnaire after adjuvant therapy.",
"reportingStatus": "POSTED",
"timeFrame": "The questionnaire was filled by the patients at screening and post adjuvant therapy.",
"title": "Patient Reported Outcomes (Global Health Status)",
"type": "SECONDARY",
"unitOfMeasure": "score on a scale"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "<p>Treatment in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression):</p><ul><li>Tumor size ≤ 2 cm: Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li><li>Tumor size > 2 cm and ≤ 4cm: Antracycline based chemotherapy followed by Paclitaxel/trastuzumab/pertuzumab (TDM-1 if residual disease)</li></ul>",
"id": "FG000",
"title": "Treatment Arm"
}
],
"periods": [
{
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "5"
}
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{
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],
"title": "Study treatment"
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{
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],
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],
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],
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{
"achievements": [
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],
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],
"title": "Follow-up after 1 year"
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"type": "STARTED"
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],
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],
"title": "Follow up at 3 yrs"
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],
"preAssignmentDetails": "<p>Out of 20 patients screened, 13 patients did not fulfill the study criteria (PAM50 subtype other than HER2-Enriched, ERBB2 high, liver metastasis, multicentric tumor).</p><p>Finally only 5 patients that fulfilled all eligibility criteria and signed the ICF were included</p>",
"recruitmentDetails": "Overall, 20 patients were screened for the study in a single study centre (clinical setting) over the duration of 18 months.\nA total of 5 patients were finally selected for the study treatment after meeting all the inclusion criteria and signing the ICF"
}
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