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NCT01275677

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Version 341 to 342 · National Cancer Institute (NCI)

Patch inspector

Version 341 to 342

58 operations 4 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
arms_or_interventions_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:05:19+00
Raw hash
53d39cffbfaaafdb5512c41afea9915eeea565084a7472663c0a52e3a4215d11
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 43 ops
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 5
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 6
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Cyclophosphamide
After
Other: Laboratory Biomarker Analysis
remove /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/4
Triage: High
Arm Intervention Change Operation 7
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Cyclophosphamide
After
Other: Laboratory Biomarker Analysis
remove /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/5
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Cyclophosphamide
After
Other: Laboratory Biomarker Analysis
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Quality-of-Life Assessment
remove /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/5
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Quality-of-Life Assessment
remove /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/5
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
add /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Cyclophosphamide
After
Other: Laboratory Biomarker Analysis
remove /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: Trastuzumab
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/5
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
After
Biological: Trastuzumab
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Doxorubicin Hydrochloride
After
Cyclophosphamide
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm IA (docetaxel, cyclophosphamide)
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm IIA (docetaxel, cyclophosphamide, trastuzumab)
add /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "(-)-Cyclophosphamide",
  "2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate",
  "Carloxan",
  "Ciclofosfamida",
  "Ciclofosfamide",
  "Cicloxal",
  "Clafen",
  "Claphene",
  "CP monohydrate",
  "CTX",
  "CYCLO-cell",
  "Cycloblastin",
  "Cycloblastine",
  "Cyclophospham",
  "Cyclophosphamid monohydrate",
  "Cyclophosphamidum",
  "Cyclophosphan",
  "Cyclophosphane",
  "Cyclophosphanum",
  "Cyclostin",
  "Cyclostine",
  "Cytophosphan",
  "Cytophosphane",
  "Cytoxan",
  "Fosfaseron",
  "Genoxal",
  "Genuxal",
  "Ledoxina",
  "Mitoxan",
  "Neosar",
  "Revimmune",
  "Syklofosfamid",
  "WR- 138719"
]
replace /protocolSection/armsInterventionsModule/interventions/1/otherNames/0
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
TXT
After
RP56976
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/1
Triage: High
Arm Intervention Change Operation 25
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Taxotere
add /protocolSection/armsInterventionsModule/interventions/1/otherNames/2
Triage: High
Arm Intervention Change Operation 26
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Taxotere Injection Concentrate
replace /protocolSection/armsInterventionsModule/interventions/2/name
Triage: High
Arm Intervention Change Operation 27
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Cyclophosphamide
After
Doxorubicin Hydrochloride
remove /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 28
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm IA (docetaxel, cyclophosphamide)
remove /protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 29
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm IIA (docetaxel, cyclophosphamide, trastuzumab)
add /protocolSection/armsInterventionsModule/interventions/2/otherNames
Triage: High
Arm Intervention Change Operation 30
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)",
  "ADM",
  "Adriacin",
  "Adriamycin",
  "Adriamycin Hydrochloride",
  "Adriamycin PFS",
  "Adriamycin RDF",
  "ADRIAMYCIN, HYDROCHLORIDE",
  "Adriamycine",
  "Adriblastina",
  "Adriblastine",
  "Adrimedac",
  "Chloridrato de Doxorrubicina",
  "DOX",
  "DOXO-CELL",
  "Doxolem",
  "Doxorubicin.HCl",
  "Doxorubin",
  "Farmiblastina",
  "FI 106",
  "FI-106",
  "hydroxydaunorubicin",
  "Rubex"
]
replace /protocolSection/armsInterventionsModule/interventions/3/type
Triage: High
Arm Intervention Change Operation 31
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
BIOLOGICAL
After
OTHER
replace /protocolSection/armsInterventionsModule/interventions/3/name
Triage: High
Arm Intervention Change Operation 32
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Trastuzumab
After
Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/interventions/3/description
Triage: High
Arm Intervention Change Operation 33
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given IV
After
Correlative studies
add /protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 34
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm IA (docetaxel, cyclophosphamide)
add /protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 35
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm IB (doxorubicin hydrochloride, cyclophosphamide)
remove /protocolSection/armsInterventionsModule/interventions/3/otherNames
Triage: High
Arm Intervention Change Operation 36
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "ABP 980",
  "PF-05280014",
  "rhuMAb HER2"
]
replace /protocolSection/armsInterventionsModule/interventions/4/otherNames/1
Triage: High
Arm Intervention Change Operation 37
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
TAX
After
Asotax
add /protocolSection/armsInterventionsModule/interventions/4/otherNames/2
Triage: High
Arm Intervention Change Operation 38
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Bristaxol
add /protocolSection/armsInterventionsModule/interventions/4/otherNames/3
Triage: High
Arm Intervention Change Operation 39
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Praxel
add /protocolSection/armsInterventionsModule/interventions/4/otherNames/4
Triage: High
Arm Intervention Change Operation 40
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Taxol
add /protocolSection/armsInterventionsModule/interventions/4/otherNames/5
Triage: High
Arm Intervention Change Operation 41
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Taxol Konzentrat
replace /protocolSection/armsInterventionsModule/interventions/6/type
Triage: High
Arm Intervention Change Operation 42
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
OTHER
After
BIOLOGICAL
replace /protocolSection/armsInterventionsModule/interventions/6/name
Triage: High
Arm Intervention Change Operation 43
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Laboratory Biomarker Analysis
After
Trastuzumab
replace /protocolSection/armsInterventionsModule/interventions/6/description
Triage: High
Arm Intervention Change Operation 44
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Correlative studies
After
Given IV
remove /protocolSection/armsInterventionsModule/interventions/6/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 45
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm IA (docetaxel, cyclophosphamide)
remove /protocolSection/armsInterventionsModule/interventions/6/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 46
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm IB (doxorubicin hydrochloride, cyclophosphamide)
add /protocolSection/armsInterventionsModule/interventions/6/otherNames
Triage: High
Arm Intervention Change Operation 47
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "ABP 980",
  "Anti-c-ERB-2",
  "Anti-c-erbB2 Monoclonal Antibody",
  "Anti-ERB-2",
  "Anti-erbB-2",
  "Anti-erbB2 Monoclonal Antibody",
  "Anti-HER2/c-erbB2 Monoclonal Antibody",
  "Anti-p185-HER2",
  "c-erb-2 Monoclonal Antibody",
  "HER2 Monoclonal Antibody",
  "Herceptin",
  "Herceptin Biosimilar PF-05280014",
  "Herceptin Trastuzumab Biosimilar PF-05280014",
  "MoAb HER2",
  "Monoclonal Antibody c-erb-2",
  "Monoclonal Antibody HER2",
  "PF-05280014",
  "rhuMAb HER2",
  "Trastuzumab Biosimilar ABP 980",
  "Trastuzumab Biosimilar PF-05280014"
]
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 11 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0
Triage: High
Secondary Outcome Change Operation 48
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "BCFS",
  "timeFrame": "From randomization until local recurrence, or death from any cause, assessed up to 10 years"
}
add /protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
Secondary Outcome Change Operation 49
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Change in HER2 mRNA level",
  "timeFrame": "From baseline to 24 months",
  "description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
}
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 50
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "BCFS",
  "timeFrame": "From randomization until local recurrence, or death from any cause, assessed up to 10 years"
}
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 51
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "RFI",
  "timeFrame": "From randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years"
}
add /protocolSection/outcomesModule/secondaryOutcomes/4
Triage: High
Secondary Outcome Change Operation 52
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Fcgamma receptor polymorphism",
  "timeFrame": "From baseline to up to 24 months",
  "description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
}
add /protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
Secondary Outcome Change Operation 53
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Incidence of adverse events using the National Cancer Institute CTCAE v4.0",
  "timeFrame": "Up to 30 days",
  "description": "The frequency and severity of adverse events will be graded."
}
replace /protocolSection/outcomesModule/secondaryOutcomes/7/measure
Triage: High
Secondary Outcome Change Operation 54
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Incidence of adverse events using the National Cancer Institute CTCAE v4.0
After
RFI
remove /protocolSection/outcomesModule/secondaryOutcomes/7/description
Triage: High
Secondary Outcome Change Operation 55
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
The frequency and severity of adverse events will be graded.
replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame
Triage: High
Secondary Outcome Change Operation 56
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 days
After
From randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years
remove /protocolSection/outcomesModule/secondaryOutcomes/8
Triage: High
Secondary Outcome Change Operation 57
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Change in HER2 mRNA level",
  "timeFrame": "From baseline to 24 months",
  "description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
}
remove /protocolSection/outcomesModule/secondaryOutcomes/8
Triage: High
Secondary Outcome Change Operation 58
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Fcgamma receptor polymorphism",
  "timeFrame": "From baseline to up to 24 months",
  "description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2015-04-08
After
2015-04-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2015-04-09
After
2015-04-10
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
add /protocolSection/identificationModule/secondaryIdInfos/5
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "U10CA012027",
  "link": "https://reporter.nih.gov/quickSearch/U10CA012027",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/7
Triage: Uncategorized
Uncategorized Operation 2
Before
{
  "id": "U10CA012027",
  "link": "https://reporter.nih.gov/quickSearch/U10CA012027",
  "type": "NIH"
}
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/5",
    "value": {
      "id": "U10CA012027",
      "link": "https://reporter.nih.gov/quickSearch/U10CA012027",
      "type": "NIH"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/7"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-04-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-04-10"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/4"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/5"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/5"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/5"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/5",
    "value": "Biological: Trastuzumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Cyclophosphamide"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Arm IA (docetaxel, cyclophosphamide)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/2",
    "value": "Arm IIA (docetaxel, cyclophosphamide, trastuzumab)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "value": [
      "(-)-Cyclophosphamide",
      "2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate",
      "Carloxan",
      "Ciclofosfamida",
      "Ciclofosfamide",
      "Cicloxal",
      "Clafen",
      "Claphene",
      "CP monohydrate",
      "CTX",
      "CYCLO-cell",
      "Cycloblastin",
      "Cycloblastine",
      "Cyclophospham",
      "Cyclophosphamid monohydrate",
      "Cyclophosphamidum",
      "Cyclophosphan",
      "Cyclophosphane",
      "Cyclophosphanum",
      "Cyclostin",
      "Cyclostine",
      "Cytophosphan",
      "Cytophosphane",
      "Cytoxan",
      "Fosfaseron",
      "Genoxal",
      "Genuxal",
      "Ledoxina",
      "Mitoxan",
      "Neosar",
      "Revimmune",
      "Syklofosfamid",
      "WR- 138719"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0",
    "value": "RP56976"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/1",
    "value": "Taxotere"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/2",
    "value": "Taxotere Injection Concentrate"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/name",
    "value": "Doxorubicin Hydrochloride"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/0"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/armGroupLabels/1"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames",
    "value": [
      "5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)",
      "ADM",
      "Adriacin",
      "Adriamycin",
      "Adriamycin Hydrochloride",
      "Adriamycin PFS",
      "Adriamycin RDF",
      "ADRIAMYCIN, HYDROCHLORIDE",
      "Adriamycine",
      "Adriblastina",
      "Adriblastine",
      "Adrimedac",
      "Chloridrato de Doxorrubicina",
      "DOX",
      "DOXO-CELL",
      "Doxolem",
      "Doxorubicin.HCl",
      "Doxorubin",
      "Farmiblastina",
      "FI 106",
      "FI-106",
      "hydroxydaunorubicin",
      "Rubex"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/type",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/name",
    "value": "Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/description",
    "value": "Correlative studies"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/0",
    "value": "Arm IA (docetaxel, cyclophosphamide)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/armGroupLabels/1",
    "value": "Arm IB (doxorubicin hydrochloride, cyclophosphamide)"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/1",
    "value": "Asotax"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/2",
    "value": "Bristaxol"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/3",
    "value": "Praxel"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/4",
    "value": "Taxol"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/5",
    "value": "Taxol Konzentrat"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/type",
    "value": "BIOLOGICAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/name",
    "value": "Trastuzumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/description",
    "value": "Given IV"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/armGroupLabels/0"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/armGroupLabels/0"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/otherNames",
    "value": [
      "ABP 980",
      "Anti-c-ERB-2",
      "Anti-c-erbB2 Monoclonal Antibody",
      "Anti-ERB-2",
      "Anti-erbB-2",
      "Anti-erbB2 Monoclonal Antibody",
      "Anti-HER2/c-erbB2 Monoclonal Antibody",
      "Anti-p185-HER2",
      "c-erb-2 Monoclonal Antibody",
      "HER2 Monoclonal Antibody",
      "Herceptin",
      "Herceptin Biosimilar PF-05280014",
      "Herceptin Trastuzumab Biosimilar PF-05280014",
      "MoAb HER2",
      "Monoclonal Antibody c-erb-2",
      "Monoclonal Antibody HER2",
      "PF-05280014",
      "rhuMAb HER2",
      "Trastuzumab Biosimilar ABP 980",
      "Trastuzumab Biosimilar PF-05280014"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0",
    "value": {
      "measure": "BCFS",
      "timeFrame": "From randomization until local recurrence, or death from any cause, assessed up to 10 years"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1",
    "value": {
      "measure": "Change in HER2 mRNA level",
      "timeFrame": "From baseline to 24 months",
      "description": "The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term.\nThe log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy."
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4",
    "value": {
      "measure": "Fcgamma receptor polymorphism",
      "timeFrame": "From baseline to up to 24 months",
      "description": "The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism.\nThe Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5",
    "value": {
      "measure": "Incidence of adverse events using the National Cancer Institute CTCAE v4.0",
      "timeFrame": "Up to 30 days",
      "description": "The frequency and severity of adverse events will be graded."
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
    "value": "RFI"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "value": "From randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8"
  }
]