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NCT01275677

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

Version 261 to 262 · National Cancer Institute (NCI)

Patch inspector

Version 261 to 262

51 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_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:04:35+00
Raw hash
61d481f9aadadc45f92e4277e15a3521271dce5c837bdfb228298561d2e4380f
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 37 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: docetaxel
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
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
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: quality-of-life assessment
After
Other: Quality-of-Life Assessment
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: doxorubicin hydrochloride
After
Drug: Doxorubicin Hydrochloride
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: cyclophosphamide
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/1/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: paclitaxel
After
Drug: Paclitaxel
replace /protocolSection/armsInterventionsModule/armGroups/1/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
Other: quality-of-life assessment
After
Other: Quality-of-Life Assessment
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/4
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
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: docetaxel
After
Drug: Docetaxel
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: cyclophosphamide
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: trastuzumab
After
Biological: Trastuzumab
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: quality-of-life assessment
After
Other: Quality-of-Life Assessment
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/4
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
Triage: High
Arm Intervention Change Operation 25
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: doxorubicin hydrochloride
After
Drug: Doxorubicin Hydrochloride
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1
Triage: High
Arm Intervention Change Operation 26
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: cyclophosphamide
After
Drug: Cyclophosphamide
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2
Triage: High
Arm Intervention Change Operation 27
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Biological: trastuzumab
After
Biological: Trastuzumab
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3
Triage: High
Arm Intervention Change Operation 28
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: paclitaxel
After
Drug: Paclitaxel
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/4
Triage: High
Arm Intervention Change Operation 29
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: quality-of-life assessment
After
Other: Quality-of-Life Assessment
replace /protocolSection/armsInterventionsModule/armGroups/3/interventionNames/5
Triage: High
Arm Intervention Change Operation 30
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 31
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
doxorubicin hydrochloride
After
Doxorubicin Hydrochloride
remove /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 32
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "ADM",
  "ADR",
  "Adria"
]
replace /protocolSection/armsInterventionsModule/interventions/1/name
Triage: High
Arm Intervention Change Operation 33
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
docetaxel
After
Docetaxel
remove /protocolSection/armsInterventionsModule/interventions/1/otherNames/0
Triage: High
Arm Intervention Change Operation 34
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
RP 56976
remove /protocolSection/armsInterventionsModule/interventions/1/otherNames/0
Triage: High
Arm Intervention Change Operation 35
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Taxotere
replace /protocolSection/armsInterventionsModule/interventions/2/name
Triage: High
Arm Intervention Change Operation 36
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
cyclophosphamide
After
Cyclophosphamide
remove /protocolSection/armsInterventionsModule/interventions/2/otherNames
Triage: High
Arm Intervention Change Operation 37
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "CPM",
  "CTX",
  "Cytoxan",
  "Endoxan",
  "Endoxana"
]
replace /protocolSection/armsInterventionsModule/interventions/3/name
Triage: High
Arm Intervention Change Operation 38
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
trastuzumab
After
Trastuzumab
replace /protocolSection/armsInterventionsModule/interventions/3/otherNames/0
Triage: High
Arm Intervention Change Operation 39
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
anti-c-erB-2
After
ABP 980
replace /protocolSection/armsInterventionsModule/interventions/3/otherNames/1
Triage: High
Arm Intervention Change Operation 40
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Herceptin
After
PF-05280014
replace /protocolSection/armsInterventionsModule/interventions/3/otherNames/2
Triage: High
Arm Intervention Change Operation 41
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
MOAB HER2
After
rhuMAb HER2
replace /protocolSection/armsInterventionsModule/interventions/4/name
Triage: High
Arm Intervention Change Operation 42
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
paclitaxel
After
Paclitaxel
remove /protocolSection/armsInterventionsModule/interventions/4/otherNames/1
Triage: High
Arm Intervention Change Operation 43
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Asotax
remove /protocolSection/armsInterventionsModule/interventions/4/otherNames/2
Triage: High
Arm Intervention Change Operation 44
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Taxol
replace /protocolSection/armsInterventionsModule/interventions/5/name
Triage: High
Arm Intervention Change Operation 45
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
quality-of-life assessment
After
Quality-of-Life Assessment
replace /protocolSection/armsInterventionsModule/interventions/5/otherNames/0
Triage: High
Arm Intervention Change Operation 46
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
quality of life assessment
After
Quality of Life Assessment
replace /protocolSection/armsInterventionsModule/interventions/6/name
Triage: High
Arm Intervention Change Operation 47
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
laboratory biomarker analysis
After
Laboratory Biomarker Analysis
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 4 ops
replace /protocolSection/contactsLocationsModule/locations/735/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 48
Before
Sheila M. Lemke
After
Sam Benjamin
replace /protocolSection/contactsLocationsModule/locations/735/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 49
Before
Sheila M. Lemke
After
Sam Benjamin
replace /protocolSection/contactsLocationsModule/locations/745/status
Triage: Uncategorized
Uncategorized Operation 50
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
remove /protocolSection/contactsLocationsModule/locations/745/contacts
Triage: Uncategorized
Uncategorized Operation 51
Before
[
  {
    "name": "Cameron B. Harkness",
    "role": "CONTACT",
    "phone": "828-670-8403"
  },
  {
    "name": "Cameron B. Harkness",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 8 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2014-11-20
After
2014-11-21
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2014-11-21
After
2014-11-24
replace /protocolSection/conditionsModule/conditions/0
Triage: Uncategorized
Uncategorized Operation 5
Before
Estrogen Receptor-negative Breast Cancer
After
Estrogen Receptor Negative
replace /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 6
Before
Estrogen Receptor-positive Breast Cancer
After
Estrogen Receptor Positive
replace /protocolSection/conditionsModule/conditions/2
Triage: Uncategorized
Uncategorized Operation 7
Before
HER2-positive Breast Cancer
After
HER2/Neu Positive
replace /protocolSection/conditionsModule/conditions/3
Triage: Uncategorized
Uncategorized Operation 8
Before
Progesterone Receptor-negative Breast Cancer
After
Progesterone Receptor Negative
replace /protocolSection/conditionsModule/conditions/4
Triage: Uncategorized
Uncategorized Operation 9
Before
Progesterone Receptor-positive Breast Cancer
After
Progesterone Receptor Positive
replace /protocolSection/conditionsModule/conditions/5
Triage: Uncategorized
Uncategorized Operation 10
Before
Recurrent Breast Cancer
After
Recurrent Breast Carcinoma
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
add /protocolSection/identificationModule/secondaryIdInfos/4
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "U10CA180868",
  "link": "https://reporter.nih.gov/quickSearch/U10CA180868",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/6
Triage: Uncategorized
Uncategorized Operation 2
Before
{
  "id": "U10CA180868",
  "link": "https://reporter.nih.gov/quickSearch/U10CA180868",
  "type": "NIH"
}
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/4",
    "value": {
      "id": "U10CA180868",
      "link": "https://reporter.nih.gov/quickSearch/U10CA180868",
      "type": "NIH"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/6"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2014-11-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2014-11-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "Estrogen Receptor Negative"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/1",
    "value": "Estrogen Receptor Positive"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/2",
    "value": "HER2/Neu Positive"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/3",
    "value": "Progesterone Receptor Negative"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/4",
    "value": "Progesterone Receptor Positive"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/5",
    "value": "Recurrent Breast Carcinoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: Docetaxel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/3",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Drug: Doxorubicin Hydrochloride"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
    "value": "Drug: Paclitaxel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/4",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: Docetaxel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2",
    "value": "Biological: Trastuzumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/3",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/4",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
    "value": "Drug: Doxorubicin Hydrochloride"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/1",
    "value": "Drug: Cyclophosphamide"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2",
    "value": "Biological: Trastuzumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/3",
    "value": "Drug: Paclitaxel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/4",
    "value": "Other: Quality-of-Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/5",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Doxorubicin Hydrochloride"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/name",
    "value": "Docetaxel"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/name",
    "value": "Cyclophosphamide"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/name",
    "value": "Trastuzumab"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames/0",
    "value": "ABP 980"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames/1",
    "value": "PF-05280014"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames/2",
    "value": "rhuMAb HER2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/name",
    "value": "Paclitaxel"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/1"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/otherNames/2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/5/name",
    "value": "Quality-of-Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/5/otherNames/0",
    "value": "Quality of Life Assessment"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/name",
    "value": "Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/735/contacts/0/name",
    "value": "Sam Benjamin"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/735/contacts/1/name",
    "value": "Sam Benjamin"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/745/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/745/contacts"
  }
]