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NCT01471106

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

Version 13 to 14 · M.D. Anderson Cancer Center

Patch inspector

Version 13 to 14

8 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
contact_admin_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 66,
    "old_value": 15,
    "pct_change": 3.4
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:14+00
Raw hash
79bb419b073e193ed671be62ded2a9914060dfe2205510e78deaa5bc63130a34
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 4
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
15
After
66
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 5
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ACTUAL
After
ESTIMATED
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
add /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 6
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 7
After
RECRUITING
add /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 8
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
After
[
  {
    "name": "Banu Arun, MD",
    "role": "CONTACT",
    "phone": "713-792-2817"
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2016-09-08
After
2016-09-27
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2016-09-09
After
2016-09-28
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 1
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2016-09-27"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2016-09-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 66
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ESTIMATED"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "Banu Arun, MD",
        "role": "CONTACT",
        "phone": "713-792-2817"
      }
    ]
  }
]