Evidence Record
evt_NCT05549505_v8_v9_5acac85ce69d
NCT05549505 · A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
Superseded Evidence Record
This page preserves the immutable v0.1.2 record. Its current successor is evt_NCT05549505_v8_v9_81d2184ee4ad.
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
Arm Intervention Change
Versions
v8 to v9
Timing
Post Recruitment
Claims Supported
- TrialDiff compared ClinicalTrials.gov record version 8 to version 9 for NCT05549505.
- The JSON Patch for this comparison has hash a376c63fd266d663c2fdf9c9d0023899ebcd8b6a27346be03c356a89701945ca.
- 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 an arm or intervention module changed between ClinicalTrials.gov versions 8 and 9.
- The timing context for the from-version record was post_recruitment.
- The deterministic rules that fired were: arms_or_interventions_change, eligibility_criteria_change.
- The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/descriptionModule/briefSummary, /protocolSection/conditionsModule/keywords/12, /protocolSection/conditionsModule/keywords/19, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1/description, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/2/description, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1, /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/1/reviewUnit, /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/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/eligibilityModule/eligibilityCriteria, /hasResults, /resultsSection, /annotationSection, /documentSection.
- An outcome path changed between versions 8 and 9 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_NCT05549505_v8_v9_5acac85ce69d. ClinicalTrials.gov NCT05549505, versions 8-9. Evidence version 1.
Event Classes
outcome_edit_cooccurs_with_results_posting Changed Paths
/protocolSection/statusModule/statusVerifiedDate
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/resultsFirstSubmitDate
/protocolSection/descriptionModule/briefSummary
/protocolSection/conditionsModule/keywords/12
/protocolSection/conditionsModule/keywords/19
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/1/label
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1/description
/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
/protocolSection/armsInterventionsModule/interventions/2/description
/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0
/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1
/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/1/reviewUnit
/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/measure
/protocolSection/outcomesModule/secondaryOutcomes/4/description
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/5/measure
/protocolSection/outcomesModule/secondaryOutcomes/5/description
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
/protocolSection/outcomesModule/secondaryOutcomes/6/measure
/protocolSection/outcomesModule/secondaryOutcomes/6/description
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame
/protocolSection/eligibilityModule/eligibilityCriteria
/hasResults
/resultsSection
/annotationSection
/documentSection
View the field-level diff for before/after values on each changed path.
Deterministic Rules
arms_or_interventions_changeeligibility_criteria_change Provenance
- Package generation
v0.1.2- Succeeded by
- evt_NCT05549505_v8_v9_81d2184ee4ad
- Patch hash
a376c63fd266d663c2fdf9c9d0023899ebcd8b6a27346be03c356a89701945ca- Canonical hash
5314158028038806fcc9526ab38c1f9f4be82ecd96f5958a51fa7f540e458c80- Rule set hash
318445b9ad266f51fd10ef378645c753ba7a098e3e4395c3c457750dc5f88d86- From snapshot
66bd37656616ab1d859cb8dd4857f3d22a8cae1e659c019190fbb9d7c5851056- To snapshot
946531f46c65ff4a2af47e4632618a073871ecbd6c491b638223f6472c1ad733- 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/lastUpdateSubmitDate",
"/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"/protocolSection/statusModule/resultsFirstSubmitDate",
"/protocolSection/descriptionModule/briefSummary",
"/protocolSection/conditionsModule/keywords/12",
"/protocolSection/conditionsModule/keywords/19",
"/protocolSection/armsInterventionsModule/armGroups/0/label",
"/protocolSection/armsInterventionsModule/armGroups/0/description",
"/protocolSection/armsInterventionsModule/armGroups/1/label",
"/protocolSection/armsInterventionsModule/armGroups/1/description",
"/protocolSection/armsInterventionsModule/interventions/0/description",
"/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"/protocolSection/armsInterventionsModule/interventions/1/description",
"/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"/protocolSection/armsInterventionsModule/interventions/2/description",
"/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0",
"/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1",
"/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/1/reviewUnit",
"/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/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"/protocolSection/eligibilityModule/eligibilityCriteria",
"/hasResults",
"/resultsSection",
"/annotationSection",
"/documentSection"
],
"citation_text": "TrialDiff Evidence Record evt_NCT05549505_v8_v9_5acac85ce69d. ClinicalTrials.gov NCT05549505, versions 8-9. Evidence version 1.",
"claims_not_supported": [
"That the amendment was scientifically unjustified.",
"That the change constitutes misconduct or wrongdoing.",
"That sponsor intent can be inferred from this registry change.",
"That the change caused or altered the trial's results.",
"That the change was or was not disclosed in a manuscript.",
"That TrialDiff determines regulatory compliance or non-compliance.",
"That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
"That event-class membership is a validated global review-priority ranking."
],
"claims_supported": [
"TrialDiff compared ClinicalTrials.gov record version 8 to version 9 for NCT05549505.",
"The JSON Patch for this comparison has hash a376c63fd266d663c2fdf9c9d0023899ebcd8b6a27346be03c356a89701945ca.",
"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 an arm or intervention module changed between ClinicalTrials.gov versions 8 and 9.",
"The timing context for the from-version record was post_recruitment.",
"The deterministic rules that fired were: arms_or_interventions_change, eligibility_criteria_change.",
"The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/descriptionModule/briefSummary, /protocolSection/conditionsModule/keywords/12, /protocolSection/conditionsModule/keywords/19, /protocolSection/armsInterventionsModule/armGroups/0/label, /protocolSection/armsInterventionsModule/armGroups/0/description, /protocolSection/armsInterventionsModule/armGroups/1/label, /protocolSection/armsInterventionsModule/armGroups/1/description, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/0/otherNames, /protocolSection/armsInterventionsModule/interventions/1/description, /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/2/description, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0, /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1, /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/1/reviewUnit, /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/measure, /protocolSection/outcomesModule/secondaryOutcomes/4/description, /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/5/measure, /protocolSection/outcomesModule/secondaryOutcomes/5/description, /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame, /protocolSection/outcomesModule/secondaryOutcomes/6/measure, /protocolSection/outcomesModule/secondaryOutcomes/6/description, /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame, /protocolSection/eligibilityModule/eligibilityCriteria, /hasResults, /resultsSection, /annotationSection, /documentSection.",
"An outcome path changed between versions 8 and 9 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
],
"classification": {
"calibration_status": "uncalibrated",
"categories": [
"arm_intervention_change",
"eligibility_change",
"results_reconciliation"
],
"category": "arm_intervention_change",
"deterministic_rules": [
"arms_or_interventions_change",
"eligibility_criteria_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": "post_recruitment",
"triage_label": "high",
"triage_rule_set_hash": "af5e5835e00a5fcfe2a17fd02b5fc244c2564104f93f78a1d77d7889f12a178b",
"value_signals": [
{
"category": "results_reconciliation",
"paths": [
"/protocolSection/outcomesModule/primaryOutcomes/0/description",
"/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"/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/description",
"/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame"
],
"severity": "low",
"signal": "results_reconciliation_outcome_suppression"
}
]
},
"event_id": "evt_NCT05549505_v8_v9_5acac85ce69d",
"evidence_version": 1,
"patch": [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2025-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2025-07-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2025-07-24"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitDate",
"value": "2025-07-04"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer."
},
{
"op": "replace",
"path": "/protocolSection/conditionsModule/keywords/12",
"value": "human epidermal growth factor receptor 2 negative"
},
{
"op": "add",
"path": "/protocolSection/conditionsModule/keywords/19",
"value": "PF-07850327"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
"value": "Arm A: ARV-471 (Experimental)"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
"value": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than Cycle 6 Day 18 [C6D18] + 14 days)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
"value": "Arm B: Anastrozole"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/description",
"value": "100 mg tablet"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
"value": "Arm A: ARV-471 (Experimental)"
},
{
"op": "add",
"path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
"value": [
"Vepdegestrant",
"PF-07850327"
]
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "1 mg tablet"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
"value": "Arm B: Anastrozole"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/description",
"value": "Surgical resection approximately 5.5 months after starting treatment (C6D18 ± 14 days)"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0",
"value": "Arm A: ARV-471 (Experimental)"
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1",
"value": "Arm B: Anastrozole"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
"value": "Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1-Ki-67 from C1D15/Ki-67 from baseline)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Baseline (during screening, prior to Day 1) and Day 15"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
"value": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.\nA serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.\nA TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last)."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Pathologic Stage at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
"value": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP).\nThe number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
"value": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
"value": "Pathological Complete Response(pCR) Rate at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).\npCR rate is the percentage of participants with pCR."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
"value": "Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
"value": "mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nTotal mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level.\nNumber of participants with score 0 was reported.\nParticipants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
"value": "Breast Conserving Surgery (BCS) Rate"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
"value": "Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "The number of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE) per mRECIST calculated.\nCR = disappearance of all target lesions, PR is >=30% decrease in sum of diameters of target lesions, progressive disease (PD) is >=20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
"value": "Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement.\nCaliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ul><li>Post-menopausal females ≥ 18 years.</li><li><p>Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment).\nER and HER2 status must be documented:</p><ul><li>ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.</li><li>HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines.</li><li>Ki-67 score ≥ 5%, analyzed locally.</li></ul></li><li>Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer.</li><li>The primary tumor must be at least 1.5 cm by imaging.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.</li><li>Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.</li></ul><p>Exclusion Criteria:</p><ul><li>Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.</li><li>Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism.</li><li>Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation).</li><li>corrected QT (Fridericia method) (QTcF) > 470 msec.</li><li>Active, uncontrolled bacterial, fungal or viral infection, including (but not limited to) hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.</li><li>Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery.</li><li>Cirrhosis meeting criteria for Child Pugh B and C.</li><li>Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents.</li><li>Any live vaccines within 14 days of planned start of first dose of study drug.</li><li>Major surgery (as defined by the Investigator) within four weeks of first dose of study drug.</li></ul>"
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"adverseEventsModule": {
"description": "Safety Analysis Set consisting of all enrolled participants who received at least 1 dose of study intervention.\nFor All-Cause Mortality, Full Analysis Set was used which included all the enrolled participants who were randomized.",
"eventGroups": [
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 102,
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "EG000",
"otherNumAffected": 72,
"otherNumAtRisk": 101,
"seriousNumAffected": 4,
"seriousNumAtRisk": 101,
"title": "Arm A: ARV-471 (Experimental)"
},
{
"deathsNumAffected": 0,
"deathsNumAtRisk": 50,
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "EG001",
"otherNumAffected": 32,
"otherNumAtRisk": 48,
"seriousNumAffected": 5,
"seriousNumAtRisk": 48,
"title": "Arm B: Anastrozole"
}
],
"frequencyThreshold": "5",
"otherEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Blood and lymphatic system disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Anaemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Ear and labyrinth disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 7,
"numAtRisk": 101,
"numEvents": 7
},
{
"groupId": "EG001",
"numAffected": 2,
"numAtRisk": 48,
"numEvents": 2
}
],
"term": "Vertigo"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 16,
"numAtRisk": 101,
"numEvents": 19
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Constipation"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Gastrointestinal disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 15,
"numAtRisk": 101,
"numEvents": 16
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 2
}
],
"term": "Nausea"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 21,
"numAtRisk": 101,
"numEvents": 24
},
{
"groupId": "EG001",
"numAffected": 5,
"numAtRisk": 48,
"numEvents": 5
}
],
"term": "Asthenia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "General disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 13,
"numAtRisk": 101,
"numEvents": 14
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Fatigue"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 101,
"numEvents": 6
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "COVID-19"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 4,
"numAtRisk": 101,
"numEvents": 4
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Nasopharyngitis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 101,
"numEvents": 10
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Urinary tract infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Investigations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 6,
"numAtRisk": 101,
"numEvents": 6
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Alanine aminotransferase increased"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Metabolism and nutrition disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 101,
"numEvents": 10
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Decreased appetite"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Musculoskeletal and connective tissue disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 14,
"numAtRisk": 101,
"numEvents": 16
},
{
"groupId": "EG001",
"numAffected": 15,
"numAtRisk": 48,
"numEvents": 15
}
],
"term": "Arthralgia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 5,
"numAtRisk": 101,
"numEvents": 5
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Dizziness"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 8,
"numAtRisk": 101,
"numEvents": 10
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Headache"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 9,
"numAtRisk": 101,
"numEvents": 10
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Insomnia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Skin and subcutaneous tissue disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 3,
"numAtRisk": 48,
"numEvents": 3
}
],
"term": "Alopecia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 25,
"numAtRisk": 101,
"numEvents": 28
},
{
"groupId": "EG001",
"numAffected": 10,
"numAtRisk": 48,
"numEvents": 10
}
],
"term": "Hot flush"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Vascular disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 12,
"numAtRisk": 101,
"numEvents": 18
},
{
"groupId": "EG001",
"numAffected": 4,
"numAtRisk": 48,
"numEvents": 4
}
],
"term": "Hypertension"
}
],
"seriousEvents": [
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 101,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Angina pectoris"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Cardiac disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 101,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Cardiac arrest"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Bacteraemia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "COVID-19"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Post procedural infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 101,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Postoperative wound infection"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Infections and infestations",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Pyelonephritis"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Injury, poisoning and procedural complications",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 101,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Post procedural haematoma"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Ataxia"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Nervous system disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 0,
"numAtRisk": 101,
"numEvents": 0
},
{
"groupId": "EG001",
"numAffected": 1,
"numAtRisk": 48,
"numEvents": 1
}
],
"term": "Encephalopathy"
},
{
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"organSystem": "Psychiatric disorders",
"sourceVocabulary": "MedDRA 27.1",
"stats": [
{
"groupId": "EG000",
"numAffected": 1,
"numAtRisk": 101,
"numEvents": 1
},
{
"groupId": "EG001",
"numAffected": 0,
"numAtRisk": 48,
"numEvents": 0
}
],
"term": "Mental status change"
}
],
"timeFrame": "From first study drug administration up to approximately 6.5 months."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "BG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "BG001",
"title": "Arm B: Anastrozole"
},
{
"description": "Total of all reporting groups",
"id": "BG002",
"title": "Total"
}
],
"measures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": "9.23",
"value": "67.4"
},
{
"groupId": "BG001",
"spread": "8.31",
"value": "66.8"
},
{
"groupId": "BG002",
"spread": "8.91",
"value": "67.2"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
]
}
],
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"title": "Age, Continuous",
"unitOfMeasure": "years"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"title": "Female"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
],
"title": "Male"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Sex: Female, Male",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "38"
},
{
"groupId": "BG001",
"value": "23"
},
{
"groupId": "BG002",
"value": "61"
}
],
"title": "Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "59"
},
{
"groupId": "BG001",
"value": "25"
},
{
"groupId": "BG002",
"value": "84"
}
],
"title": "Not Hispanic or Latino"
},
{
"measurements": [
{
"groupId": "BG000",
"value": "5"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "7"
}
],
"title": "Unknown or Not Reported"
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Ethnicity (NIH/OMB)",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "1"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "American Indian or Alaska Native"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "1"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "Asian"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "0"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "Native Hawaiian or Other Pacific Islander"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "1"
},
{
"groupId": "BG001",
"value": "2"
},
{
"groupId": "BG002",
"value": "3"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "Black or African American"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "98"
},
{
"groupId": "BG001",
"value": "46"
},
{
"groupId": "BG002",
"value": "144"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "White"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "0"
},
{
"groupId": "BG001",
"value": "1"
},
{
"groupId": "BG002",
"value": "1"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "Other"
},
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"value": "2"
},
{
"groupId": "BG001",
"value": "0"
},
{
"groupId": "BG002",
"value": "2"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "102"
},
{
"groupId": "BG001",
"value": "50"
},
{
"groupId": "BG002",
"value": "152"
}
],
"units": "Participants"
}
],
"title": "Unknown or Not Reported"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"title": "Race/Ethnicity, Customized",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "BG000",
"spread": "14.01",
"value": "20.6"
},
{
"groupId": "BG001",
"spread": "12.25",
"value": "20.1"
},
{
"groupId": "BG002",
"spread": "13.42",
"value": "20.4"
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "BG000",
"value": "100"
},
{
"groupId": "BG001",
"value": "48"
},
{
"groupId": "BG002",
"value": "148"
}
],
"units": "Participants"
}
]
}
],
"description": "Ki-67 expression assessed by immunohistochemical staining in a central laboratory.",
"dispersionType": "STANDARD_DEVIATION",
"paramType": "MEAN",
"populationDescription": "Only participants with evaluable central Ki-67 results included in the analysis.",
"title": "Percentage of Tumor Cells Positive for Ki -67",
"unitOfMeasure": "Percentage of tumor cells with Ki67"
}
],
"populationDescription": "Full Analysis Set (FAS) included all the enrolled participants who were randomized."
},
"moreInfoModule": {
"certainAgreement": {
"piSponsorEmployee": false,
"restrictiveAgreement": true
},
"pointOfContact": {
"email": "clinicaltrialsARV-471@arvinas.com",
"organization": "Arvinas Estrogen Receptor, Inc",
"phone": "475-345-3366",
"title": "Arvinas Estrogen Receptor, Inc."
}
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "60.6",
"upperLimit": "79.3",
"value": "71.4"
},
{
"groupId": "OG001",
"lowerLimit": "57.8",
"upperLimit": "82.6",
"value": "72.9"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "93"
},
{
"groupId": "OG001",
"value": "46"
}
],
"units": "Participants"
}
],
"description": "Tumor biopsy Ki-67 expression (% of tumor cells that are positive for Ki-67) at baseline and Cycle 1 Day 15 (C1D15) was collected.\nKi-67 expression was assessed by immunohistochemical staining in a central laboratory.\nThe log-transformed Ki-67 after approximately 2 weeks of treatment as a percentage of the baseline value, ie, the ratio between the Ki-67 measurements obtained from C1D15 visit and baseline was modelled using a generalized linear model (GLM) with both stratification factors (ie, baseline Ki-67 score and the tumor size) and treatment as co-variates.\nThe treatment effects were back transformed into geometric means and their Confidence Intervals.\nThe percent change, in other words, relative reduction, of Ki-67 after 2 weeks of treatment is reported as the complement of the ratio between the Ki-67 measurement from C1D15 and baseline, that is 100% × (1-Ki-67 from C1D15/Ki-67 from baseline).",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG001",
"title": "Arm B: Anastrozole"
}
],
"measureCategoriesReviewUnit": {
"resetReasons": [
"The Measure Type appears inaccurate."
]
},
"paramType": "NUMBER",
"populationDescription": "Ki-67 Evaluable Set included all enrolled participants who were randomized and received at least one dose of study treatment and had evaluable central Ki-67 measurements other than '0' or '< 1' from baseline and evaluable Ki-67 measurements from C1D15 visits.",
"reportingStatus": "POSTED",
"timeFrame": "Baseline (during screening, prior to Day 1) and Day 15",
"title": "Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies",
"type": "PRIMARY",
"unitOfMeasure": "Percent reduction"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "82"
},
{
"groupId": "OG001",
"value": "37"
}
]
}
],
"title": "TEAEs"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4"
},
{
"groupId": "OG001",
"value": "5"
}
]
}
],
"title": "Serious TEAEs"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "4"
}
]
}
],
"title": "TEAEs leading to study drug discontinuation"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "101"
},
{
"groupId": "OG001",
"value": "48"
}
],
"units": "Participants"
}
],
"description": "An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.\nAn AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.\nA serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.\nA TEAE is an AE that emerges or worsens on/after the first dose of ARV-471/Anastrozole to 30 days after the last administration of the study intervention (ie, study drug treatment or surgical resection, whichever occurs last).",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG001",
"title": "Arm B: Anastrozole"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Safety Analysis Set which consisted of all enrolled participants who received at least 1 dose of study intervention.",
"reportingStatus": "POSTED",
"timeFrame": "From signing of consent to minimum of 30 days after last administration of study drug (up to approximately 6.5 months)",
"title": "Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Study Drug Discontinuation",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypTx"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypT0"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypTis"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypT1mi"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "6"
},
{
"groupId": "OG001",
"value": "1"
}
]
}
],
"title": "Pathologic Tumor ypT1a"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "7"
},
{
"groupId": "OG001",
"value": "2"
}
]
}
],
"title": "Pathologic Tumor ypT1b"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "36"
},
{
"groupId": "OG001",
"value": "14"
}
]
}
],
"title": "Pathologic Tumor ypT1c"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "33"
},
{
"groupId": "OG001",
"value": "21"
}
]
}
],
"title": "Pathologic Tumor ypT2"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4"
},
{
"groupId": "OG001",
"value": "2"
}
]
}
],
"title": "Pathologic Tumor ypT3"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypT4a"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypT4b"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathologic Tumor ypT4c"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
},
{
"groupId": "OG001",
"value": "10"
}
]
}
],
"title": "Pathologic Tumor Not Evaluable"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypNX"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "51"
},
{
"groupId": "OG001",
"value": "20"
}
]
}
],
"title": "Pathological Lymph Nodes ypN0"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN0(i+)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "5"
},
{
"groupId": "OG001",
"value": "4"
}
]
}
],
"title": "Pathological Lymph Nodes ypN1"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN0(mol+)"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "4"
},
{
"groupId": "OG001",
"value": "3"
}
]
}
],
"title": "Pathological Lymph Nodes ypN1mi"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "21"
},
{
"groupId": "OG001",
"value": "6"
}
]
}
],
"title": "Pathological Lymph Nodes ypN1a"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN1b"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN1c"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "2"
},
{
"groupId": "OG001",
"value": "2"
}
]
}
],
"title": "Pathological Lymph Nodes ypN2"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "4"
}
]
}
],
"title": "Pathological Lymph Nodes ypN2a"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN2b"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN3"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "3"
},
{
"groupId": "OG001",
"value": "1"
}
]
}
],
"title": "Pathological Lymph Nodes ypN3a"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN3b"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "0"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
],
"title": "Pathological Lymph Nodes ypN3c"
},
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "12"
},
{
"groupId": "OG001",
"value": "10"
}
]
}
],
"title": "Pathological Lymph Nodes Not evaluable"
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "102"
},
{
"groupId": "OG001",
"value": "50"
}
],
"units": "Participants"
}
],
"description": "<p>Local pathological assessment of the tissue from surgical resection (performed after approximately 5.5 months of treatment), at minimum, included pathologic stage (ypT and ypN stage) as described in the Statistical Analysis Plan (SAP).\nThe number of participants with the following disease staging at post-surgery are summarized:</p><p>Pathologic Tumor - ypT (ypTx, ypT0, ypTis, ypT1mi, ypT1a, ypT1b, ypT1c, ypT2, ypT3, ypT4a, ypT4b, ypT4c) Pathological Lymph Nodes - ypN (ypNX, ypN0, ypN0[i+], ypN0[mol+], ypN1, ypN1mi, ypN1a, ypN1b, ypN1c, ypN2, ypN2a, ypN2b, ypN3, ypN3a, ypN3b, ypN3c).</p>",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG001",
"title": "Arm B: Anastrozole"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized.",
"reportingStatus": "POSTED",
"reviewUnit": {
"resetReasons": [
"The description of the scale or categories does not include sufficient information to understand the results reported."
]
},
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"title": "Pathologic Stage at the Time of Surgical Resection",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "1"
},
{
"groupId": "OG001",
"value": "0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "102"
},
{
"groupId": "OG001",
"value": "50"
}
],
"units": "Participants"
}
],
"description": "pCR is defined as no invasive cancer in the breast and sampled axillary lymph nodes following completion of neoadjuvant systemic therapy (ie, Pathologic Tumor - ypT = ypT0 or ypTis, and Pathologic Lymph Nodes - ypN = ypN0 in the current American Joint Committee on Cancer (AJCC) staging system).\npCR rate is the percentage of participants with pCR.",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG001",
"title": "Arm B: Anastrozole"
}
],
"paramType": "NUMBER",
"populationDescription": "Full Analysis set included all the enrolled participants who were randomized.",
"reportingStatus": "POSTED",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"title": "Pathological Complete Response(pCR) Rate at the Time of Surgical Resection",
"type": "SECONDARY",
"unitOfMeasure": "percentage of participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"value": "21"
},
{
"groupId": "OG001",
"value": "10"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "102"
},
{
"groupId": "OG001",
"value": "50"
}
],
"units": "Participants"
}
],
"description": "mPEPI score was derived from factors assigned a numerical score following Neoadjuvant endocrine treatment (NET).\nTotal mPEPI score assigned to each patient was the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage and Ki67 level.\nNumber of participants with score 0 was reported.\nParticipants with mPEPI score of 0 have pathological stage pT1 or pT2, negative lymph nodes pN0 and proliferation index [Ki-67] of less than or equal to 2.7%.",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG001",
"title": "Arm B: Anastrozole"
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized.",
"reportingStatus": "POSTED",
"timeFrame": "At Cycle 6 Day 18 (approximately 5.5 months), each cycle is 28 days",
"title": "Number of Participants With Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0 at the Time of Surgical Resection",
"type": "SECONDARY",
"unitOfMeasure": "Participants"
},
{
"classes": [
{
"categories": [
{
"measurements": [
{
"groupId": "OG000",
"lowerLimit": "60.1",
"upperLimit": "77.7",
"value": "69.6"
},
{
"groupId": "OG001",
"lowerLimit": "40.4",
"upperLimit": "67.0",
"value": "54.0"
}
]
}
]
}
],
"denoms": [
{
"counts": [
{
"groupId": "OG000",
"value": "102"
},
{
"groupId": "OG001",
"value": "50"
}
],
"units": "Participants"
}
],
"description": "Breast conserving surgery (BCS) Rate is the percentage of participants received breast conserving surgery.",
"dispersionType": "95% Confidence Interval",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
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}
],
"paramType": "NUMBER",
"populationDescription": "Full Analysis Set included all the enrolled participants who were randomized.",
"reportingStatus": "POSTED",
"timeFrame": "At Cycle 6 (from Day 141 to Day 168), each cycle is 28 days",
"title": "Breast Conserving Surgery (BCS) Rate",
"type": "SECONDARY",
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},
{
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{
"categories": [
{
"measurements": [
{
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{
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}
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}
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{
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{
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}
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}
],
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{
"categories": [
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"measurements": [
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{
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{
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{
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{
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{
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{
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"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
"id": "OG000",
"title": "Arm A: ARV-471 (Experimental)"
},
{
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"id": "OG001",
"title": "Arm B: Anastrozole"
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],
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"title": "Radiographic Response Per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in Primary Tumor During Cycle 6",
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"unitOfMeasure": "Participants"
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{
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"measurements": [
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{
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}
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}
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"denoms": [
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},
{
"groupId": "OG001",
"value": "19"
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],
"units": "Participants"
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],
"description": "The percentage change from the baseline of the primary breast tumor size in physical exam calculated in caliper measurement.\nCaliper-based response is the maximum percentage decrease or minimum percentage increase if there is no decrease per participant.",
"dispersionType": "Standard Deviation",
"groups": [
{
"description": "Participants received 200 mg ARV-471 (2*100 mg tablets) once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
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"title": "Arm A: ARV-471 (Experimental)"
},
{
"description": "Participants received 1 mg Anastrozole tablet orally once daily for approximately 5.5 months prior to undergoing surgical resection (no later than C6D18 + 14 days).",
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"title": "Arm B: Anastrozole"
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],
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"reportingStatus": "POSTED",
"timeFrame": "Baseline (Day 1) and Cycle 6 Day 1 (At Day 141), each cycle is 28 days",
"title": "Percentage Change From Baseline at Cycle 6 Day 1 in Caliper Measurement of the Primary Tumor",
"type": "SECONDARY",
"unitOfMeasure": "Percent change"
}
]
},
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},
{
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{
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},
{
"groupId": "FG001",
"numSubjects": "3"
}
],
"type": "Withdrawal by Subject"
},
{
"reasons": [
{
"groupId": "FG000",
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},
{
"groupId": "FG001",
"numSubjects": "6"
}
],
"type": "Other: Miscellaneous"
}
],
"milestones": [
{
"achievements": [
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"groupId": "FG000",
"numSubjects": "102"
},
{
"groupId": "FG001",
"numSubjects": "50"
}
],
"type": "STARTED"
},
{
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"groupId": "FG000",
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},
{
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],
"type": "Treated"
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{
"achievements": [
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"groupId": "FG000",
"numSubjects": "94"
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{
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],
"type": "COMPLETED"
},
{
"achievements": [
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"groupId": "FG000",
"numSubjects": "8"
},
{
"groupId": "FG001",
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}
],
"type": "NOT COMPLETED"
}
],
"title": "Overall Study"
}
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"preAssignmentDetails": "A total of 152 participants were enrolled."
}
}
},
{
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"unpostedEvents": [
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