Evidence Record
evt_NCT01124695_v128_v129_7ec316f2bed9
NCT01124695 · Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
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
Design Change
Versions
v128 to v129
Timing
Late Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 128 to version 129 for NCT01124695.
- The JSON Patch for this comparison has hash 45d5451679480ab07ab77b64fe741e652387e9e4e3a2f04db67dd0bee7c5da66.
- The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.
- 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 study design module changed between ClinicalTrials.gov versions 128 and 129.
- The timing context for the from-version record was late_recruitment.
- The deterministic rules that fired were: arms_or_interventions_change, design_info_change, eligibility_criteria_change, enrollment_count_change, enrollment_type_change.
- The changed JSON Pointer paths were: /protocolSection/identificationModule/orgStudyIdInfo/id, /protocolSection/identificationModule/secondaryIdInfos/0/id, /protocolSection/identificationModule/secondaryIdInfos/0/type, /protocolSection/identificationModule/secondaryIdInfos/0/domain, /protocolSection/identificationModule/secondaryIdInfos/1, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/sponsorCollaboratorsModule/leadSponsor/name, /protocolSection/descriptionModule/detailedDescription, /protocolSection/conditionsModule/conditions/1, /protocolSection/conditionsModule/keywords/1, /protocolSection/designModule/designInfo/allocation, /protocolSection/designModule/designInfo/interventionModel, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/interventions/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/armGroups, /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, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/eligibilityModule/maximumAge, /protocolSection/ipdSharingStatementModule/ipdSharing, /protocolSection/ipdSharingStatementModule/description, /annotationSection, /hasResults, /resultsSection, /documentSection.
- The enrollment count changed by at least 20 percent.
- An outcome path changed between versions 128 and 129 in a patch that also carried a hasResults or resultsSection co-occurrence signal.
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.
Neutral Review Question
What source document explains this registry amendment, and does it change interpretation of the trial record?
Citation
TrialDiff Evidence Record evt_NCT01124695_v128_v129_7ec316f2bed9. ClinicalTrials.gov NCT01124695, versions 128-129. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/identificationModule/orgStudyIdInfo/id
/protocolSection/identificationModule/secondaryIdInfos/0/id
/protocolSection/identificationModule/secondaryIdInfos/0/type
/protocolSection/identificationModule/secondaryIdInfos/0/domain
/protocolSection/identificationModule/secondaryIdInfos/1
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/statusModule/resultsFirstSubmitQcDate
/protocolSection/statusModule/resultsFirstPostDateStruct
/protocolSection/sponsorCollaboratorsModule/leadSponsor/name
/protocolSection/descriptionModule/detailedDescription
/protocolSection/conditionsModule/conditions/1
/protocolSection/conditionsModule/keywords/1
/protocolSection/designModule/designInfo/allocation
/protocolSection/designModule/designInfo/interventionModel
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/armsInterventionsModule/interventions/0/name
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1
/protocolSection/armsInterventionsModule/armGroups
/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
/protocolSection/outcomesModule/secondaryOutcomes/3/measure
/protocolSection/outcomesModule/secondaryOutcomes/3/description
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/4
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/eligibilityModule/maximumAge
/protocolSection/ipdSharingStatementModule/ipdSharing
/protocolSection/ipdSharingStatementModule/description
/annotationSection
/hasResults
/resultsSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
arms_or_interventions_changedesign_info_changeeligibility_criteria_changeenrollment_count_changeenrollment_type_change Provenance
- Package generation
v0.1.3(active)- Supersedes
- evt_NCT01124695_v128_v129_a4b1eab1300b
- Patch hash
45d5451679480ab07ab77b64fe741e652387e9e4e3a2f04db67dd0bee7c5da66- Canonical hash
35e2eda191109715d6cf26bb1e3cd962505ee5f2b84e51fb90de39e329c040cd- Rule set hash
fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621- From snapshot
7e0ffd0148e29e3d2973323640478de88d7b266fbe36381907ad18069768996b- To snapshot
1490cb18f35ae9c979db44b06f149a61f202616ca2ef75957f6c34e6f930280b- Patch source
- ctgov_internal_history
- Generated at
- 2026-08-03T06:46:43.000Z
- Source URL
- Registry payload
Canonical JSON Preview
Stored payload{
"changed_paths": [
"/protocolSection/identificationModule/orgStudyIdInfo/id",
"/protocolSection/identificationModule/secondaryIdInfos/0/id",
"/protocolSection/identificationModule/secondaryIdInfos/0/type",
"/protocolSection/identificationModule/secondaryIdInfos/0/domain",
"/protocolSection/identificationModule/secondaryIdInfos/1",
"/protocolSection/statusModule/statusVerifiedDate",
"/protocolSection/statusModule/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/statusModule/resultsFirstSubmitQcDate",
"/protocolSection/statusModule/resultsFirstPostDateStruct",
"/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
"/protocolSection/descriptionModule/detailedDescription",
"/protocolSection/conditionsModule/conditions/1",
"/protocolSection/conditionsModule/keywords/1",
"/protocolSection/designModule/designInfo/allocation",
"/protocolSection/designModule/designInfo/interventionModel",
"/protocolSection/designModule/enrollmentInfo/count",
"/protocolSection/designModule/enrollmentInfo/type",
"/protocolSection/armsInterventionsModule/interventions/0/name",
"/protocolSection/armsInterventionsModule/interventions/0/description",
"/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
"/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"/protocolSection/armsInterventionsModule/interventions/1",
"/protocolSection/armsInterventionsModule/armGroups",
"/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",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4",
"/protocolSection/eligibilityModule/eligibilityCriteria",
"/protocolSection/eligibilityModule/maximumAge",
"/protocolSection/ipdSharingStatementModule/ipdSharing",
"/protocolSection/ipdSharingStatementModule/description",
"/annotationSection",
"/hasResults",
"/resultsSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT01124695_v128_v129_7ec316f2bed9. ClinicalTrials.gov NCT01124695, versions 128-129. 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 128 to version 129 for NCT01124695.",
"The JSON Patch for this comparison has hash 45d5451679480ab07ab77b64fe741e652387e9e4e3a2f04db67dd0bee7c5da66.",
"The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
"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 study design module changed between ClinicalTrials.gov versions 128 and 129.",
"The timing context for the from-version record was late_recruitment.",
"The deterministic rules that fired were: arms_or_interventions_change, design_info_change, eligibility_criteria_change, enrollment_count_change, enrollment_type_change.",
"The changed JSON Pointer paths were: /protocolSection/identificationModule/orgStudyIdInfo/id, /protocolSection/identificationModule/secondaryIdInfos/0/id, /protocolSection/identificationModule/secondaryIdInfos/0/type, /protocolSection/identificationModule/secondaryIdInfos/0/domain, /protocolSection/identificationModule/secondaryIdInfos/1, /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/sponsorCollaboratorsModule/leadSponsor/name, /protocolSection/descriptionModule/detailedDescription, /protocolSection/conditionsModule/conditions/1, /protocolSection/conditionsModule/keywords/1, /protocolSection/designModule/designInfo/allocation, /protocolSection/designModule/designInfo/interventionModel, /protocolSection/designModule/enrollmentInfo/count, /protocolSection/designModule/enrollmentInfo/type, /protocolSection/armsInterventionsModule/interventions/0/name, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1, /protocolSection/armsInterventionsModule/armGroups, /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, /protocolSection/outcomesModule/secondaryOutcomes/3/measure, /protocolSection/outcomesModule/secondaryOutcomes/3/description, /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/4, /protocolSection/eligibilityModule/eligibilityCriteria, /protocolSection/eligibilityModule/maximumAge, /protocolSection/ipdSharingStatementModule/ipdSharing, /protocolSection/ipdSharingStatementModule/description, /annotationSection, /hasResults, /resultsSection, /documentSection.",
"The enrollment count changed by at least 20 percent.",
"An outcome path changed between versions 128 and 129 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"design_change",
"arm_intervention_change",
"eligibility_change",
"enrollment_change",
"results_reconciliation"
],
"category": "design_change",
"deterministic_rules": [
"arms_or_interventions_change",
"design_info_change",
"eligibility_criteria_change",
"enrollment_count_change",
"enrollment_type_change"
],
"event_class_rule_set_hash": "74a6f55a686c29aa023171acd6b43f27ea95f2b0af2d49094ac70287ba4e502c",
"event_classes": [
"outcome_edit_cooccurs_with_results_posting"
],
"rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
"severity": "high",
"severity_pre_timing": "high",
"timing_context": "late_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "enrollment_change",
"new_value": 124,
"old_value": 240,
"path": "/protocolSection/designModule/enrollmentInfo/count",
"pct_change": 0.4833,
"severity": "high",
"signal": "enrollment_count_change_ge_20pct"
},
{
"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",
"/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/4"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT01124695_v128_v129_7ec316f2bed9",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/identificationModule/orgStudyIdInfo/id",
"value": "E3108"
},
{
"op": "replace",
"path": "/protocolSection/identificationModule/secondaryIdInfos/0/id",
"value": "E3108"
},
{
"op": "add",
"path": "/protocolSection/identificationModule/secondaryIdInfos/0/type",
"value": "OTHER"
},
{
"op": "add",
"path": "/protocolSection/identificationModule/secondaryIdInfos/0/domain",
"value": "ECOG-ACRIN Cancer Research Group"
},
{
"op": "add",
"path": "/protocolSection/identificationModule/secondaryIdInfos/1",
"value": {
"id": "U10CA180794",
"link": "https://reporter.nih.gov/quickSearch/U10CA180794",
"type": "NIH"
}
},
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-02"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-02-13"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-03-14"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2022-09-07"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-02-13"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-03-14",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
"value": "ECOG-ACRIN Cancer Research Group"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>OBJECTIVES:</p><p>Primary</p><ul><li>To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS)</li></ul><p>Secondary</p><ul><li>To correlate CYP2D6 score (0 vs 1 vs 2) and PFS</li><li>To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months.</li><li>To correlate endoxifen concentration with response</li><li>To correlate CYP2D6 with response</li><li>To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes</li></ul><p>OUTLINE: This is a multicenter study.</p><p>Patients receive oral tamoxifen citrate once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.</p><p>Blood, plasma, and tissue samples are collected periodically for laboratory studies.</p><p>After completion of study therapy, patients are followed up every 3-6 months for 5 years.</p>"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/conditions/1",
"value": "Stage IV Breast Cancer"
},
{
"op": "remove",
"path": "/protocolSection/conditionsModule/keywords/1"
},
{
"op": "add",
"path": "/protocolSection/designModule/designInfo/allocation",
"value": "NA"
},
{
"op": "add",
"path": "/protocolSection/designModule/designInfo/interventionModel",
"value": "SINGLE_GROUP"
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/count",
"value": 124
},
{
"op": "replace",
"path": "/protocolSection/designModule/enrollmentInfo/type",
"value": "ACTUAL"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/name",
"value": "tamoxifen"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "PO"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
"value": [
"Tamoxifen"
]
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"value": [
"tamoxifen citrate",
"Nolvadex",
"NSC# 180973"
]
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/interventions/1"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/armGroups",
"value": [
{
"description": "Patients receive oral tamoxifen citrate once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.",
"interventionNames": [
"Drug: tamoxifen"
],
"label": "Tamoxifen",
"type": "EXPERIMENTAL"
}
]
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Progression-free Survival by CYP2D6 Status in 2 Categories"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Assessed every 3 months for 2 years, then every 6 months up to 5 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Progression-free Survival by CYP2D6 Status in 3 Categories"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Assessed every 3 months for 2 years, then every 6 months up to 5 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Proportion of Patients Progression-free at 6 Months"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "Assessed every 3 months for 6 months"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Proportion of Patients With Response"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response.\nEither complete response (CR) or partial response (PR) is considered as response.\nCR is defined as disappearance of all lesions.\nPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "Assessed every 3 months for 2 years, then every 6 months up to 5 years"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Endoxifen Concentration by Response"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "<p>Endoxifen (ng/ml) was assessed at cycle 3.</p><p>Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response.\nEither complete response (CR) or partial response (PR) is considered as response.\nCR is defined as disappearance of all lesions.\nPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Endoxifen was assessed at cycle 3; response was assessed every 3 months for 2 years, then every 6 months up to 5 years"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
"value": {
"description": "<p>This is a landmark progression-free survival analysis at 3 months post registration.\nOnly patients who were progression-free and alive at 3 months were included.</p><p>Progression-free survival in this analysis is defined as the time from 3 months post registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.</p>",
"measure": "Progression-free Survival From 3 Months Post Registration",
"timeFrame": "Assessed every 3 months for 2 years, then every 6 months up to 5 years"
}
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li><p>Histologically confirmed adenocarcinoma of the breast</p><ul><li>Stage III (locally advanced), metastatic, or recurrent disease</li><li>Deemed not resectable</li></ul></li><li><p>Estrogen-receptor and/or progesterone-receptor positive disease</p><ul><li>Receptor status is based on most recent results</li></ul></li><li>Measurable or non-measurable disease</li><li>ECOG performance status 0-2</li><li>History of central nervous system (CNS) metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms</li><li>Total bilirubin ≤ 1.5 times upper limit of normal (ULN)</li><li>Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)</li><li>Negative pregnancy test</li><li>Fertile patients must use effective nonhormonal contraception</li><li>Disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix</li><li>Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy; other prior non-hormonal investigational agents in the adjuvant setting must have been completed at least 4 weeks prior to study registration and should be discussed with the study PI</li><li>Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose</li><li>Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation</li><li>Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting</li><li><p>At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:</p><ul><li>Paroxetine (Paxil)</li><li>Fluoxetine (Prozac)</li><li>Bupropion (Wellbutrin)</li><li>Quinidine (Cardioquin)</li></ul></li><li><p>Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:</p><ul><li>Radiotherapy was initiated before study entry</li><li>Sites of measurable or non-measurable disease are outside the radiotherapy port</li><li>Recovered from prior radiotherapy</li></ul></li></ul><p>Exclusion Criteria:</p><ul><li>Pregnant or nursing</li><li>Concurrent chemotherapy</li><li>Leptomeningeal disease</li><li>Non-protocol concurrent hormonal therapy</li><li>Medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities</li><li>Prior tamoxifen for advanced disease</li><li>More than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics</li><li><p>Starting bisphosphonate therapy while receiving treatment on this study</p><ul><li>Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration</li></ul></li></ul>"
},
{
"op": "remove",
"path": "/protocolSection/eligibilityModule/maximumAge"
},
{
"op": "replace",
"path": "/protocolSection/ipdSharingStatementModule/ipdSharing",
"value": "YES"
},
{
"op": "add",
"path": "/protocolSection/ipdSharingStatementModule/description",
"value": "Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy."
},
{
"op": "remove",
"path": "/annotationSection"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "<p>All patients enrolled are included in all-cause mortality analysis.\nPatients who received treatment with adverse event data available are included in AE analysis.</p><p>This is a single-arm study, so adverse events are reported for the Tamoxifen arm only, which is reported per arm.</p>",
"eventGroups": [
{
"deathsNumAffected": 69,
"deathsNumAtRisk": 124,
"description": "Patients receive oral tamoxifen citrate at 20 mg once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.",
"id": "EG000",
"otherNumAffected": 18,
"otherNumAtRisk": 122,
"seriousNumAffected": 30,
"seriousNumAtRisk": 122,
"title": "Tamoxifen"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 18,
"numAtRisk": 122
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 11,
"numAtRisk": 122
}
],
"term": "Hot flashes"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 10,
"numAtRisk": 122
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 122
}
],
"term": "Edema limbs"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 122
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 14,
"numAtRisk": 122
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 122
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 122
}
],
"term": "Aspartate aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 122
}
],
"term": "Anorexia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 122
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 17,
"numAtRisk": 122
}
],
"term": "Back pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 122
}
],
"term": "Bone pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 122
}
],
"term": "Anxiety"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 122
}
],
"term": "Insomnia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 122
}
],
"term": "Dyspnea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 122
}
],
"term": "Hypertension"
}
],
"seriousEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Anemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Aspartate aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 122
}
],
"term": "Lymphocyte count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Platelet count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hypercalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 122
}
],
"term": "Hypertriglyceridemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 122
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 122
}
],
"term": "Back pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 122
}
],
"term": "Bone pain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Peripheral motor neuropathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Peripheral sensory neuropathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Thromboembolic event"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hearing impaired"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Atrial fibrillation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Heart failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Pericardial tamponade"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Death NOS"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Edema limbs"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Skin ulceration"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Urticaria"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Diarrhea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Obstruction gastric"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Pancreatitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Vomiting"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Hepatobiliary disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Cholecystitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Joint infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Sepsis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Skin infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Alanine aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Alkaline phosphatase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Creatinine increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Neutrophil count decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Weight gain"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "White blood cell decreased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Acidosis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Glucose intolerance"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hyperglycemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hyperkalemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hypocalcemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hypoglycemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Obesity"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Muscle weakness lower limb"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Pain in extremity"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Dizziness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Neoplasms benign, malignant and unspecified (incl cysts and polyps)",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Neoplasms - Other"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Confusion"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 122
}
],
"term": "Dyspnea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Respiratory failure"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 2,
"numAtRisk": 122
}
],
"term": "Acute kidney injury"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Renal and urinary disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Chronic kidney disease"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Surgical and medical procedures",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Surgical and medical procedures - Other"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 3,
"numAtRisk": 122
}
],
"term": "Hypertension"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "CTCAE 4.0",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 122
}
],
"term": "Hypotension"
}
],
"timeFrame": "Assessed every 4 weeks while on treatment and for 30 days after the end of treatment up to 5 years"
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "113"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Patients receive oral tamoxifen citrate at 20 mg once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.",
"id": "BG000",
"title": "Tamoxifen"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"lowerLimit": "36",
"upperLimit": "94",
"value": "62"
}
]
}
]
}
],
"dispersionType": "FULL_RANGE",
"paramType": "MEDIAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "111"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
}
],
"title": "Male"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "33"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "77"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "American Indian or Alaska Native"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "7"
}
],
"title": "Asian"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "6"
}
],
"title": "Black or African American"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "97"
}
],
"title": "White"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
}
],
"title": "More than one race"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "3"
}
],
"title": "Unknown or Not Reported"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
}
],
"title": "Poor metabolizer"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "27"
}
],
"title": "Intermediate metabolizer"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "50"
}
],
"title": "Normal metabolizer"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "6"
}
],
"title": "Ultra-rapid metabolizer"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "28"
}
],
"title": "Missing"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "CYP2D6 phenotype",
"unitOfMeasure": "Participants"
}
],
"populationDescription": "Eligible and treated patients are included in this analysis.\nThis is the primary analysis population."
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictionType": "LTE60",
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "eatrials@jimmy.harvard.edu",
"organization": "ECOG-ACRIN Statistical Office",
"phone": "617-632-3012",
"title": "Study Statistician"
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Only 2 patients were in this category.\nAmong these two, one was censored at baseline.\nAs only one patient contributed data, the 95% CI could not be calculated.",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA",
"value": "12.9"
},
{
"groupId": "OG001",
"lowerLimit": "4.4",
"upperLimit": "8.5",
"value": "6.9"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "83"
}
],
"units": "Participants"
}
],
"description": "Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Patients with CYP2D6 score of 0 are considered as poor metabolizer (PM).",
"id": "OG000",
"title": "CYP2D6 - PM"
},
{
"description": "<p>Patients with CYP2D6 score >0 are included in the IM+NM+UM group.</p><p>Intermediate metabolizer (IM): CYP2D6 score >0 and <=1 Normal metabolizer (NM): CYP2D6 score >1 and <=2 Ultra-rapid metabolizer (UM): CYP2D6 score >2</p>",
"id": "OG001",
"title": "CYP2D6 - (IM+NM+UM)"
}
],
"paramType": "MEDIAN",
"populationDescription": "Eligible and treated patients who had a sample from baseline evaluable for CYP2D6 phenotype",
"reportingStatus": "POSTED",
"timeFrame": "Assessed every 3 months for 2 years, then every 6 months up to 5 years",
"title": "Progression-free Survival by CYP2D6 Status in 2 Categories",
"type": "PRIMARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"comment": "Only 2 patients were in this category.\nAmong these two, one was censored at baseline.\nAs only one patient contributed data, the 95% CI could not be calculated.",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA",
"value": "12.9"
},
{
"groupId": "OG001",
"lowerLimit": "2.7",
"upperLimit": "13.8",
"value": "4.8"
},
{
"groupId": "OG002",
"lowerLimit": "4.9",
"upperLimit": "10.3",
"value": "7.4"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "27"
},
{
"groupId": "OG002",
"value": "56"
}
],
"units": "Participants"
}
],
"description": "Progression-free survival is defined as the time from registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Patients with CYP2D6 score of 0 are considered as poor metabolizer (PM).",
"id": "OG000",
"title": "CYP2D6 - PM"
},
{
"description": "Intermediate metabolizer (IM): CYP2D6 score >0 and <=1",
"id": "OG001",
"title": "CYP2D6 - IM"
},
{
"description": "<p>Patients with CYP2D6 score >1 are included in the NM+UM group.</p><p>Normal metabolizer (NM): CYP2D6 score >1 and <=2 Ultra-rapid metabolizer (UM): CYP2D6 score >2</p>",
"id": "OG002",
"title": "CYP2D6 - NM+UM"
}
],
"paramType": "MEDIAN",
"populationDescription": "Eligible and treated patients who had a sample from baseline evaluable for CYP2D6 phenotype",
"reportingStatus": "POSTED",
"timeFrame": "Assessed every 3 months for 2 years, then every 6 months up to 5 years",
"title": "Progression-free Survival by CYP2D6 Status in 3 Categories",
"type": "SECONDARY",
"unitOfMeasure": "months"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "0.16",
"upperLimit": "1.00",
"value": "1.0"
},
{
"groupId": "OG001",
"lowerLimit": "0.39",
"upperLimit": "0.62",
"value": "0.50"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "83"
}
],
"units": "Participants"
}
],
"description": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Patients with CYP2D6 score of 0 are considered as poor metabolizer (PM).",
"id": "OG000",
"title": "CYP2D6 - PM"
},
{
"description": "<p>Patients with CYP2D6 score >0 are included in the IM+NM+UM group.</p><p>Intermediate metabolizer (IM): CYP2D6 score >0 and <=1 Normal metabolizer (NM): CYP2D6 score >1 and <=2 Ultra-rapid metabolizer (UM): CYP2D6 score >2</p>",
"id": "OG001",
"title": "CYP2D6 - (IM+NM+UM)"
}
],
"paramType": "NUMBER",
"populationDescription": "Eligible and treated patients who had a sample from baseline evaluable for CYP2D6 phenotype",
"reportingStatus": "POSTED",
"timeFrame": "Assessed every 3 months for 6 months",
"title": "Proportion of Patients Progression-free at 6 Months",
"type": "SECONDARY",
"unitOfMeasure": "proportion of participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "0.0",
"upperLimit": "0.84",
"value": "0"
},
{
"groupId": "OG001",
"lowerLimit": "0.07",
"upperLimit": "0.22",
"value": "0.13"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "83"
}
],
"units": "Participants"
}
],
"description": "Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response.\nEither complete response (CR) or partial response (PR) is considered as response.\nCR is defined as disappearance of all lesions.\nPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Patients with CYP2D6 score of 0 are considered as poor metabolizer (PM).",
"id": "OG000",
"title": "CYP2D6 - PM"
},
{
"description": "<p>Patients with CYP2D6 score >0 are included in the IM+NM+UM group.</p><p>Intermediate metabolizer (IM): CYP2D6 score >0 and <=1 Normal metabolizer (NM): CYP2D6 score >1 and <=2 Ultra-rapid metabolizer (UM): CYP2D6 score >2</p>",
"id": "OG001",
"title": "CYP2D6 - (IM+NM+UM)"
}
],
"paramType": "NUMBER",
"populationDescription": "Eligible and treated patients who had a sample from baseline evaluable for CYP2D6 phenotype",
"reportingStatus": "POSTED",
"timeFrame": "Assessed every 3 months for 2 years, then every 6 months up to 5 years",
"title": "Proportion of Patients With Response",
"type": "SECONDARY",
"unitOfMeasure": "proportion of participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "7.5",
"upperLimit": "45.2",
"value": "17.5"
},
{
"groupId": "OG001",
"lowerLimit": "2.0",
"upperLimit": "67.9",
"value": "17.2"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "6"
},
{
"groupId": "OG001",
"value": "57"
}
],
"units": "Participants"
}
],
"description": "<p>Endoxifen (ng/ml) was assessed at cycle 3.</p><p>Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate response.\nEither complete response (CR) or partial response (PR) is considered as response.\nCR is defined as disappearance of all lesions.\nPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</p>",
"dispersionType": "Full Range",
"groups": [
{
"description": "Patients with CR or PR per RECIST 1.1",
"id": "OG000",
"title": "Responders"
},
{
"description": "Patients without CR or PR per RECIST 1.1",
"id": "OG001",
"title": "Non-responders"
}
],
"paramType": "MEDIAN",
"populationDescription": "Eligible and treated patients who had a sample at cycle 3 for endoxifen concentration evaluation",
"reportingStatus": "POSTED",
"timeFrame": "Endoxifen was assessed at cycle 3; response was assessed every 3 months for 2 years, then every 6 months up to 5 years",
"title": "Endoxifen Concentration by Response",
"type": "SECONDARY",
"unitOfMeasure": "ng/ml"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "6.5",
"upperLimit": "16.6",
"value": "13.8"
},
{
"groupId": "OG001",
"lowerLimit": "5.3",
"upperLimit": "19.3",
"value": "11.1"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "21"
},
{
"groupId": "OG001",
"value": "22"
}
],
"units": "Participants"
}
],
"description": "<p>This is a landmark progression-free survival analysis at 3 months post registration.\nOnly patients who were progression-free and alive at 3 months were included.</p><p>Progression-free survival in this analysis is defined as the time from 3 months post registration to progression or death, whichever occurs first.\nResponse Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression.\nProgression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).\nIn addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.</p>",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Patients with endoxifen at 3 months higher than median (15.5 ng/ml)",
"id": "OG000",
"title": "Endoxifen High"
},
{
"description": "Patients with endoxifen at 3 months lower than or equal to median (15.5 ng/ml)",
"id": "OG001",
"title": "Endoxifen Low"
}
],
"paramType": "MEDIAN",
"populationDescription": "Eligible and treated patients who had endoxifen level assessed at 3 months and were progression-free and alive at 3 months from registration",
"reportingStatus": "POSTED",
"timeFrame": "Assessed every 3 months for 2 years, then every 6 months up to 5 years",
"title": "Progression-free Survival From 3 Months Post Registration",
"type": "SECONDARY",
"unitOfMeasure": "months"
}
]
},
"participantFlowModule": {
"groups": [
{
"description": "Patients receive oral tamoxifen citrate at 20 mg once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.",
"id": "FG000",
"title": "Tamoxifen"
}
],
"periods": [
{
"dropWithdraws": [
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "77"
}
],
"type": "Disease progression"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "11"
}
],
"type": "Adverse Event"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "Death"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "7"
}
],
"type": "Withdrawal by Subject"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
}
],
"type": "Physician Decision"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "9"
}
],
"type": "Alternative therapy"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "4"
}
],
"type": "No documentation that patient went off treatment"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "9"
}
],
"type": "Ineligible"
},
{
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
}
],
"type": "Ineligible and never start treatment"
}
],
"milestones": [
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "124"
}
],
"type": "STARTED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "122"
}
],
"type": "Treated"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "113"
}
],
"type": "Eligible and Treated"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "85"
}
],
"type": "Eligible and Treated and Had CYP2D6 Score"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "63"
}
],
"type": "Eligible and Treated and Had Cycle 3 Edoxifen Evaluation"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "43"
}
],
"type": "Eligible and Treated Patients With 3-month Endoxifen and Were Progression-free and Alive at 3 Months"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "1"
}
],
"type": "COMPLETED"
},
{
"achievements": [
{
"groupId": "FG000",
"numSubjects": "123"
}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
],
"recruitmentDetails": "The study was activated on September 21, 2010 and closed on October 22, 2015 for a total of 124 patients enrolled."
}
}
},
{
"op": "add",
"path": "/documentSection",
"value": {
"largeDocumentModule": {
"largeDocs": [
{
"date": "2014-05-01",
"filename": "Prot_SAP_000.pdf",
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"hasProtocol": true,
"hasSap": true,
"label": "Study Protocol and Statistical Analysis Plan",
"size": 608025,
"typeAbbrev": "Prot_SAP",
"uploadDate": "2022-08-25T16:19"
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"patch_source": "ctgov_internal_history",
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"to_snapshot_hash": "1490cb18f35ae9c979db44b06f149a61f202616ca2ef75957f6c34e6f930280b"
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"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/NCT01124695",
"nct_id": "NCT01124695"
},
"versions": {
"from_version": 128,
"submitted_date": "2023-02-13",
"to_version": 129
}
}