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NCT03283384

Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.

Version 1 to 2 · Borstkanker Onderzoek Groep

Patch inspector

Version 1 to 2

33 operations 6 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
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2018-04",
    "old_value": "2018-02",
    "delta_days": 59,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:34+00
Raw hash
357c97e0a152de31a0521bd3fdc9b1bb10c63790b6ade0c9f0527795b732d648
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 3 ops
replace /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
All patients initially start with two weeks of letrozole treatment.
Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)).
After
All patients initially start with two weeks of letrozole treatment.
Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)).
replace /protocolSection/armsInterventionsModule/armGroups/2/description
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
All patients initially start with two weeks of letrozole treatment.
Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)).
After
All patients initially start with two weeks of letrozole treatment.
Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)).
replace /protocolSection/armsInterventionsModule/interventions/1/description
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
AC-T chemotherapy: 4 cycles of AC (adriamycin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v.
bolus, respectively) 3-weekly, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m² weekly).
After
Dose dense AC-T chemotherapy: 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v.
bolus, respectively) 2-weekly plus G-CSF 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m² weekly).
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2018-02
After
2018-04
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 23 ops
add /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 11
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 12
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 13
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 14
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 15
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 16
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 17
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/7/status
Triage: Uncategorized
Uncategorized Operation 18
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 19
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/9/status
Triage: Uncategorized
Uncategorized Operation 20
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/10/status
Triage: Uncategorized
Uncategorized Operation 21
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/11/status
Triage: Uncategorized
Uncategorized Operation 22
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/12/status
Triage: Uncategorized
Uncategorized Operation 23
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/13/status
Triage: Uncategorized
Uncategorized Operation 24
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/14/status
Triage: Uncategorized
Uncategorized Operation 25
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/15/status
Triage: Uncategorized
Uncategorized Operation 26
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/16/status
Triage: Uncategorized
Uncategorized Operation 27
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/17/status
Triage: Uncategorized
Uncategorized Operation 28
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/18/status
Triage: Uncategorized
Uncategorized Operation 29
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/19/status
Triage: Uncategorized
Uncategorized Operation 30
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/20/status
Triage: Uncategorized
Uncategorized Operation 31
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/21/status
Triage: Uncategorized
Uncategorized Operation 32
After
NOT_YET_RECRUITING
add /protocolSection/contactsLocationsModule/locations/22/status
Triage: Uncategorized
Uncategorized Operation 33
After
NOT_YET_RECRUITING
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2018-02
After
2018-04
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2018-02-05
After
2018-04-25
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2018-02-06
After
2018-04-27
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 7
Before
Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%).
After
Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (dose dense AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%).
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
add /protocolSection/oversightModule/isUsExport
Triage: Uncategorized
Uncategorized Operation 6
After
true
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
NOT_YET_RECRUITING
After
RECRUITING
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2018-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-04-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-04-27"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isUsExport",
    "value": true
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (dose dense AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "value": "All patients initially start with two weeks of letrozole treatment.\nPatients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks))."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
    "value": "All patients initially start with two weeks of letrozole treatment.\nPatients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks))."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/description",
    "value": "Dose dense AC-T chemotherapy: 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v.\nbolus, respectively) 2-weekly plus G-CSF 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m² weekly)."
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/2/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/3/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/4/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/5/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/6/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/8/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/9/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/10/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/11/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/12/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/13/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/14/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/15/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/16/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/17/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/18/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/19/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/20/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/21/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/22/status",
    "value": "NOT_YET_RECRUITING"
  }
]