Back to trial

NCT01471106

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Version 18 to 19 · M.D. Anderson Cancer Center

Patch inspector

Version 18 to 19

10 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
contact_admin_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "later",
    "new_value": "2014-01-21",
    "old_value": "2014-01",
    "delta_days": 20,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 26,
    "old_value": 66,
    "pct_change": 0.6061
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:15+00
Raw hash
3bbfe6931da8b665dcb9361e7229b850940553bf9e3f40a0f93328e61fd5a2de
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 6
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
66
After
26
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 7
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
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
2014-01
After
2014-01-21
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 8
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Banu Arun, MD",
    "role": "CONTACT",
    "phone": "713-792-2817"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 9
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 10
Before
RECRUITING
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2017-10
After
2018-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2017-10-20
After
2018-08-20
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2017-10-24
After
2018-08-22
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
RECRUITING
After
ACTIVE_NOT_RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2014-01-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-08-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-08-22"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 26
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/centralContacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status"
  }
]