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NCT03734029

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Version 28 to 29 · Daiichi Sankyo

Patch inspector

Version 28 to 29

73 operations 5 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
adverse_event_group_changeother_adverse_event_modificationother_adverse_event_removal
Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/6/description"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:50+00
Raw hash
d5bcf9e87d3510dfa2c3ff1155351e62291d0ebfadb04437dd8030c6b10a616f
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 4
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
Adverse events and safety Posted serious or other adverse event data. Triage: High 29 ops
replace /resultsSection/adverseEventsModule/description
Triage: Uncategorized
Uncategorized Operation 39
Before
The Safety Analysis Set included all randomized participants who received at least 1 dose of treatment.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with that product.
A TEAE was an AE that occurred, having been absent before the first dose of study drug, or worsened in severity or seriousness after initiating study drug up to 47 days after the last dose of the study drug.
After
Safety events were assessed in the Safety Analysis Set, participants who received ≥1 dose of treatment.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with that product.
The treatment of Physician's Choice arm was based on the label approved in the country of drug administration.
The Physician's Choice group was combined for an appropriate sample size for the comparator group.
replace /resultsSection/adverseEventsModule/eventGroups/0/description
Triage: High
Adverse Event Group Change Operation 40
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected
Triage: High
Adverse Event Group Change Operation 41
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
369
After
366
replace /resultsSection/adverseEventsModule/eventGroups/1/otherNumAffected
Triage: High
Adverse Event Group Change Operation 42
Matched rules
  • adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority.
Before
169
After
167
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 43
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
139
After
137
replace /resultsSection/adverseEventsModule/otherEvents/0/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 44
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
45
After
44
replace /resultsSection/adverseEventsModule/otherEvents/1/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 45
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
31
After
29
replace /resultsSection/adverseEventsModule/otherEvents/3/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 46
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
282
After
281
replace /resultsSection/adverseEventsModule/otherEvents/4/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 47
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
150
After
148
replace /resultsSection/adverseEventsModule/otherEvents/5/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 48
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
126
After
124
replace /resultsSection/adverseEventsModule/otherEvents/14/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 49
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
50
After
49
replace /resultsSection/adverseEventsModule/otherEvents/15/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 50
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
70
After
69
replace /resultsSection/adverseEventsModule/otherEvents/16/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 51
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
46
After
42
replace /resultsSection/adverseEventsModule/otherEvents/17/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 52
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
11
After
10
replace /resultsSection/adverseEventsModule/otherEvents/18/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 53
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
25
After
24
replace /resultsSection/adverseEventsModule/otherEvents/19/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 54
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
29
After
27
remove /resultsSection/adverseEventsModule/otherEvents/20
Triage: High
Other Adverse Event Removal Operation 55
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Medication error",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 371,
      "numAffected": 0
    },
    {
      "groupId": "EG001",
      "numAtRisk": 172,
      "numAffected": 11
    }
  ],
  "organSystem": "Injury, poisoning and procedural complications",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 24.0"
}
replace /resultsSection/adverseEventsModule/otherEvents/21/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 56
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
62
After
61
replace /resultsSection/adverseEventsModule/otherEvents/24/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 57
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
73
After
72
replace /resultsSection/adverseEventsModule/otherEvents/25/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 58
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
60
After
59
replace /resultsSection/adverseEventsModule/otherEvents/28/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 59
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
26
After
25
replace /resultsSection/adverseEventsModule/otherEvents/32/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 60
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
39
After
38
replace /resultsSection/adverseEventsModule/otherEvents/36/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 61
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
34
After
33
replace /resultsSection/adverseEventsModule/otherEvents/39/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 62
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
54
After
53
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 63
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
38
After
34
replace /resultsSection/adverseEventsModule/otherEvents/47/stats/1/numAffected
Triage: Medium
Other Adverse Event Modification Operation 64
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
16
After
14
replace /resultsSection/adverseEventsModule/otherEvents/48/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 65
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
36
After
35
replace /resultsSection/adverseEventsModule/otherEvents/49/stats/0/numAffected
Triage: Medium
Other Adverse Event Modification Operation 66
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
28
After
21
remove /resultsSection/adverseEventsModule/otherEvents/50
Triage: High
Other Adverse Event Removal Operation 67
Matched rules
  • other_adverse_event_removal Removal of other adverse event result data is high review priority.
Before
{
  "term": "Interstitial lung disease",
  "stats": [
    {
      "groupId": "EG000",
      "numAtRisk": 371,
      "numAffected": 23
    },
    {
      "groupId": "EG001",
      "numAtRisk": 172,
      "numAffected": 1
    }
  ],
  "organSystem": "Respiratory, thoracic and mediastinal disorders",
  "assessmentType": "SYSTEMATIC_ASSESSMENT",
  "sourceVocabulary": "MedDRA 24.0"
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 5 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 5
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /protocolSection/outcomesModule/secondaryOutcomes/3/description
Triage: High
Secondary Outcome Change Operation 6
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /protocolSection/outcomesModule/secondaryOutcomes/4/description
Triage: High
Secondary Outcome Change Operation 7
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /protocolSection/outcomesModule/secondaryOutcomes/5/description
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
ORR is defined as the number of participants with complete and partial responses.
After
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
replace /protocolSection/outcomesModule/secondaryOutcomes/6/description
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
ORR is defined as the number of participants with complete and partial responses.
After
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 12 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2023-01
After
2023-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2023-01-11
After
2023-02-15
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2023-02-10
After
2023-03-14
replace /resultsSection/participantFlowModule/preAssignmentDetails
Triage: Uncategorized
Uncategorized Operation 10
Before
All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting.
After
All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting.
The treatment chosen for the Physician's Choice arm was based on the label approved in the country of drug administration.
The Physician's Choice group was combined to ensure an appropriate sample size for the comparator group.
replace /resultsSection/participantFlowModule/groups/0/description
Triage: Uncategorized
Uncategorized Operation 11
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/baselineCharacteristicsModule/groups/0/description
Triage: Uncategorized
Uncategorized Operation 12
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
Triage: Uncategorized
Uncategorized Operation 68
Before
2023-02-09
After
2023-03-13
add /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/1
Triage: Uncategorized
Uncategorized Operation 69
After
{
  "date": "2023-03-16",
  "type": "RELEASE"
}
add /annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/2
Triage: Uncategorized
Uncategorized Operation 70
After
{
  "date": "2023-04-10",
  "type": "RESET"
}
replace /documentSection/largeDocumentModule/largeDocs/0/date
Triage: Uncategorized
Uncategorized Operation 71
Before
2022-10-12
After
2020-10-12
remove /documentSection/largeDocumentModule/reviewUnit
Triage: Uncategorized
Uncategorized Operation 72
Before
{
  "resetReasons": [
    "The Document Type or Document Date appear inconsistent with information in an uploaded study document."
  ]
}
add /reviewUnit
Triage: Uncategorized
Uncategorized Operation 73
After
{
  "resetReasons": [
    "Issues noted on a previous submission of this record do not appear to have been addressed."
  ]
}
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 26 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description
Triage: Uncategorized
Uncategorized Operation 13
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/0/description
Triage: Uncategorized
Uncategorized Operation 14
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description
Triage: Uncategorized
Uncategorized Operation 15
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/0/description
Triage: Uncategorized
Uncategorized Operation 16
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/0/description
Triage: Uncategorized
Uncategorized Operation 17
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/0/description
Triage: Uncategorized
Uncategorized Operation 18
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/description
Triage: Uncategorized
Uncategorized Operation 19
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/paramType
Triage: Uncategorized
Uncategorized Operation 20
Before
NUMBER
After
MEDIAN
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/0/description
Triage: Uncategorized
Uncategorized Operation 21
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/4/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 22
Before
{
  "resetReasons": [
    "The Measure Type appears inaccurate."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description
Triage: Uncategorized
Uncategorized Operation 23
Before
Progression-free survival (PFS) was defined as the time from the date of randomization to the first objective documentation of radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
After
Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first.
PFS was based on investigator assessment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1.
Median PFS was from Kaplan-Meier analysis.
Confidence interval for median was computed using the Brookmeyer-Crowley method.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/paramType
Triage: Uncategorized
Uncategorized Operation 24
Before
NUMBER
After
MEDIAN
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/0/description
Triage: Uncategorized
Uncategorized Operation 25
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 26
Before
{
  "resetReasons": [
    "The Measure Type appears inaccurate."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description
Triage: Uncategorized
Uncategorized Operation 27
Before
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
ORR is defined as the number of participants with complete and partial responses.
After
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/0/description
Triage: Uncategorized
Uncategorized Operation 28
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/10/title
Triage: Uncategorized
Uncategorized Operation 29
Before
BICR: Objective response rate
After
BICR: Confirmed Objective response rate
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/classes/11/title
Triage: Uncategorized
Uncategorized Operation 30
Before
Investigator: Objective response rate
After
Investigator: Confirmed Objective response rate
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/6/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 31
Before
{
  "resetReasons": [
    "Information within the measure appears inconsistent."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description
Triage: Uncategorized
Uncategorized Operation 32
Before
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
ORR is defined as the number of participants with complete and partial responses.
After
Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.
Complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Confirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/0/description
Triage: Uncategorized
Uncategorized Operation 33
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/10/title
Triage: Uncategorized
Uncategorized Operation 34
Before
BICR: Objective response rate
After
BICR: Confirmed Objective response rate
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/classes/11/title
Triage: Uncategorized
Uncategorized Operation 35
Before
Investigator: Objective response rate
After
Investigator: Confirmed Objective response rate
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/7/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 36
Before
{
  "resetReasons": [
    "Information within the measure appears inconsistent."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/0/description
Triage: Uncategorized
Uncategorized Operation 37
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/0/description
Triage: Uncategorized
Uncategorized Operation 38
Before
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to DS8201a with an initial dose of 5.4 mg/kg was infused for approximately 90 minutes.
If there was no infusion-related reaction (IRR), doses of T-DXd after the initial dose of 5.4 mg/kg were infused for a minimum of 30 minutes.
After
Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.
If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.
Raw JSON Patch 
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    "value": "Best overall response rate and confirmed objective response rate (ORR) were assessed by blinded independent central review (BICR) and investigator assessment.\nComplete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.\nConfirmed ORR was defined as the number of participants with complete and partial responses and confirmed by a second assessment."
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    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/0/description",
    "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/0/description",
    "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
  },
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  {
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    "value": "Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes.\nIf there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes."
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