Back to trial

NCT01142401

Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Version 2 to 3 · National Cancer Institute (NCI)

Patch inspector

Version 2 to 3

21 operations 8 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_changedesign_info_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": null,
    "old_type": null,
    "severity": "medium",
    "direction": "later",
    "new_value": "2010-06",
    "old_value": "2010-01",
    "delta_days": 151,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:08+00
Raw hash
3ed8d7b1fdab239d75f6f52406ec63231a832ca4fd0f51cbbb415092632f60c6
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 11
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Median progression-free survival
After
Clinical benefit rate in patients for at least 24 weeks
add /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 12
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
1.7 years for enrollment plus 1 year of follow-up
remove /protocolSection/outcomesModule/primaryOutcomes/1
Triage: Critical
Primary Outcome Change Operation 13
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "measure": "Clinical benefit rate in patients for at least 24 weeks"
}
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
add /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 10
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
PARALLEL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 5 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
1.7 years for enrollment plus 1 year of follow-up
add /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
1.7 years for enrollment plus 1 year of follow-up
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Adverse event profile
After
Clinical benefit rate at 12 and 24 weeks in patients who crossover from fulvestrant alone to the combination treatment
add /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
1.7 years for enrollment plus 1 year of follow-up
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Clinical benefit rate at 12 and 24 weeks in patients who crossover from fulvestrant alone to the combination treatment"
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2010-01
After
2010-06
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 2 ops
add /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 19
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
After
[
  {
    "name": "Kerin Adelson, MD",
    "role": "CONTACT",
    "email": "kerin.adelson@mssm.edu",
    "phone": "212-241-2299"
  },
  {
    "name": "Joseph Sparano, MD",
    "role": "CONTACT",
    "email": "jsparano@montefiore.org",
    "phone": "718-904-2555"
  }
]
add /protocolSection/contactsLocationsModule/locations
Triage: Uncategorized
Uncategorized Operation 20
After
[
  {
    "zip": "06030",
    "city": "Farmington",
    "state": "Connecticut",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Susan Tannenbaum, MD",
        "role": "CONTACT",
        "email": "stannenbaum@uchc.edu",
        "phone": "860-679-2474"
      },
      {
        "name": "Susan Tannenbaum, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ],
    "facility": "University of Connecticut Health Center",
    "geoPoint": {
      "lat": 41.71982,
      "lon": -72.83204
    }
  },
  {
    "zip": "11220",
    "city": "Brooklyn",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Susan Burdette-Radoux, MD",
        "role": "CONTACT",
        "email": "sburdette-radoux@maimonides.org",
        "phone": "718-765-2644"
      },
      {
        "name": "Susan Burdette-Radoux, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Alan Astrow, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "William Solomon, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Yiqing Xu, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Lech Dabrowski, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Philip Rubin, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Maimonides Cancer Center",
    "geoPoint": {
      "lat": 40.6501,
      "lon": -73.94958
    }
  },
  {
    "zip": "10016",
    "city": "New York",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Yelena Novik, MD",
        "role": "CONTACT",
        "email": "yelena.novik@nyumc.org",
        "phone": "212-731-5350"
      },
      {
        "name": "Yelena Novik, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Franco Muggia, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "James Speyer, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Amy Tierste, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Matthew Volm, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "New York University",
    "geoPoint": {
      "lat": 40.71427,
      "lon": -74.00597
    }
  },
  {
    "zip": "10021",
    "city": "New York",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Tessa Cigler, MD",
        "role": "CONTACT",
        "phone": "212-821-0644"
      },
      {
        "name": "Tessa Cigler, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Linda Vahdat, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Ellen Chuang",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Weill Medical College- Cornell",
    "geoPoint": {
      "lat": 40.71427,
      "lon": -74.00597
    }
  },
  {
    "zip": "10029",
    "city": "New York",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Kerin Adelson, MD",
        "role": "CONTACT",
        "email": "kerin.adelson@mssm.edu",
        "phone": "212-241-2299"
      },
      {
        "name": "Kerin Adelson, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "George Raptis, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Tisch Cancer Center- Mount Sinai School of Medicine",
    "geoPoint": {
      "lat": 40.71427,
      "lon": -74.00597
    }
  },
  {
    "zip": "10031",
    "city": "New York",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Dawn Hershman, MD",
        "role": "CONTACT",
        "email": "dlh23@columbia.edu",
        "phone": "212-305-1945"
      },
      {
        "name": "Susan Refice",
        "role": "CONTACT",
        "phone": "212-305-0176"
      },
      {
        "name": "Dawn Hershman, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Karen Crew, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Kevin Kalinsky, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Columbia Presbyterian Medical Center",
    "geoPoint": {
      "lat": 40.71427,
      "lon": -74.00597
    }
  },
  {
    "zip": "10461",
    "city": "The Bronx",
    "state": "New York",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Joseph Sparano, MD",
        "role": "CONTACT",
        "email": "jsparano@montefiore.org",
        "phone": "718-904-2555"
      },
      {
        "name": "Lisa Escobar",
        "role": "CONTACT",
        "email": "lescobar@montefiore.org",
        "phone": "718-904-2730"
      },
      {
        "name": "Joseph Sparano, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Christine Pellegrino, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Petra Rietschel, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Montefiore Medical Center",
    "geoPoint": {
      "lat": 40.84985,
      "lon": -73.86641
    }
  },
  {
    "zip": "43210",
    "city": "Columbus",
    "state": "Ohio",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Bhuvaneswari Ramaswamy, MD",
        "role": "CONTACT",
        "email": "bhuvaneswar.ramaswamy@osumc.edu",
        "phone": "614-293-6401"
      },
      {
        "name": "Bhuvaneswari Ramaswamy, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      },
      {
        "name": "Kari Kendra, MD",
        "role": "SUB_INVESTIGATOR"
      },
      {
        "name": "Ewa Mrozek, MD",
        "role": "SUB_INVESTIGATOR"
      }
    ],
    "facility": "Ohio State University",
    "geoPoint": {
      "lat": 39.96118,
      "lon": -82.99879
    }
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2010-06
After
2011-03
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2010-08-03
After
2011-03-07
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2010-08-04
After
2011-03-09
add /protocolSection/statusModule/expandedAccessInfo
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "hasExpandedAccess": false
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 4 ops
replace /protocolSection/identificationModule/organization/fullName
Triage: Uncategorized
Uncategorized Operation 1
Before
National Cancer Institute (NCI)
After
Montefiore Medical Center
replace /protocolSection/identificationModule/organization/class
Triage: Uncategorized
Uncategorized Operation 2
Before
NIH
After
OTHER
replace /protocolSection/sponsorCollaboratorsModule/leadSponsor/name
Triage: Uncategorized
Uncategorized Operation 9
Before
Albert Einstein College of Medicine
After
Montefiore Medical Center
add /protocolSection/oversightModule
Triage: Uncategorized
Uncategorized Operation 21
After
{
  "oversightHasDmc": 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 4
Before
NOT_YET_RECRUITING
After
RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/fullName",
    "value": "Montefiore Medical Center"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/class",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2011-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2010-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2011-03-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2011-03-09"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/expandedAccessInfo",
    "value": {
      "hasExpandedAccess": false
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
    "value": "Montefiore Medical Center"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Clinical benefit rate in patients for at least 24 weeks"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "1.7 years for enrollment plus 1 year of follow-up"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "1.7 years for enrollment plus 1 year of follow-up"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "1.7 years for enrollment plus 1 year of follow-up"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Clinical benefit rate at 12 and 24 weeks in patients who crossover from fulvestrant alone to the combination treatment"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "1.7 years for enrollment plus 1 year of follow-up"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "Kerin Adelson, MD",
        "role": "CONTACT",
        "email": "kerin.adelson@mssm.edu",
        "phone": "212-241-2299"
      },
      {
        "name": "Joseph Sparano, MD",
        "role": "CONTACT",
        "email": "jsparano@montefiore.org",
        "phone": "718-904-2555"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations",
    "value": [
      {
        "zip": "06030",
        "city": "Farmington",
        "state": "Connecticut",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Susan Tannenbaum, MD",
            "role": "CONTACT",
            "email": "stannenbaum@uchc.edu",
            "phone": "860-679-2474"
          },
          {
            "name": "Susan Tannenbaum, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          }
        ],
        "facility": "University of Connecticut Health Center",
        "geoPoint": {
          "lat": 41.71982,
          "lon": -72.83204
        }
      },
      {
        "zip": "11220",
        "city": "Brooklyn",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Susan Burdette-Radoux, MD",
            "role": "CONTACT",
            "email": "sburdette-radoux@maimonides.org",
            "phone": "718-765-2644"
          },
          {
            "name": "Susan Burdette-Radoux, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Alan Astrow, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "William Solomon, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Yiqing Xu, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Lech Dabrowski, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Philip Rubin, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Maimonides Cancer Center",
        "geoPoint": {
          "lat": 40.6501,
          "lon": -73.94958
        }
      },
      {
        "zip": "10016",
        "city": "New York",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Yelena Novik, MD",
            "role": "CONTACT",
            "email": "yelena.novik@nyumc.org",
            "phone": "212-731-5350"
          },
          {
            "name": "Yelena Novik, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Franco Muggia, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "James Speyer, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Amy Tierste, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Matthew Volm, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "New York University",
        "geoPoint": {
          "lat": 40.71427,
          "lon": -74.00597
        }
      },
      {
        "zip": "10021",
        "city": "New York",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Tessa Cigler, MD",
            "role": "CONTACT",
            "phone": "212-821-0644"
          },
          {
            "name": "Tessa Cigler, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Linda Vahdat, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Ellen Chuang",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Weill Medical College- Cornell",
        "geoPoint": {
          "lat": 40.71427,
          "lon": -74.00597
        }
      },
      {
        "zip": "10029",
        "city": "New York",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Kerin Adelson, MD",
            "role": "CONTACT",
            "email": "kerin.adelson@mssm.edu",
            "phone": "212-241-2299"
          },
          {
            "name": "Kerin Adelson, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "George Raptis, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Tisch Cancer Center- Mount Sinai School of Medicine",
        "geoPoint": {
          "lat": 40.71427,
          "lon": -74.00597
        }
      },
      {
        "zip": "10031",
        "city": "New York",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Dawn Hershman, MD",
            "role": "CONTACT",
            "email": "dlh23@columbia.edu",
            "phone": "212-305-1945"
          },
          {
            "name": "Susan Refice",
            "role": "CONTACT",
            "phone": "212-305-0176"
          },
          {
            "name": "Dawn Hershman, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Karen Crew, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Kevin Kalinsky, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Columbia Presbyterian Medical Center",
        "geoPoint": {
          "lat": 40.71427,
          "lon": -74.00597
        }
      },
      {
        "zip": "10461",
        "city": "The Bronx",
        "state": "New York",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Joseph Sparano, MD",
            "role": "CONTACT",
            "email": "jsparano@montefiore.org",
            "phone": "718-904-2555"
          },
          {
            "name": "Lisa Escobar",
            "role": "CONTACT",
            "email": "lescobar@montefiore.org",
            "phone": "718-904-2730"
          },
          {
            "name": "Joseph Sparano, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Christine Pellegrino, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Petra Rietschel, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Montefiore Medical Center",
        "geoPoint": {
          "lat": 40.84985,
          "lon": -73.86641
        }
      },
      {
        "zip": "43210",
        "city": "Columbus",
        "state": "Ohio",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Bhuvaneswari Ramaswamy, MD",
            "role": "CONTACT",
            "email": "bhuvaneswar.ramaswamy@osumc.edu",
            "phone": "614-293-6401"
          },
          {
            "name": "Bhuvaneswari Ramaswamy, MD",
            "role": "PRINCIPAL_INVESTIGATOR"
          },
          {
            "name": "Kari Kendra, MD",
            "role": "SUB_INVESTIGATOR"
          },
          {
            "name": "Ewa Mrozek, MD",
            "role": "SUB_INVESTIGATOR"
          }
        ],
        "facility": "Ohio State University",
        "geoPoint": {
          "lat": 39.96118,
          "lon": -82.99879
        }
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule",
    "value": {
      "oversightHasDmc": true
    }
  }
]