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NCT02086578

Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions

Version 1 to 2 · Memorial Sloan Kettering Cancer Center

Patch inspector

Version 1 to 2

10 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_changeeligibility_criteria_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:07+00
Raw hash
21bd3618133c26f61ed5083034b4cac80381492069df4c36d55b36e9c5949eb1
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 4
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Physical examination by MD, Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.
Total length of the follow-up time will be 24 ± 2 months post-IMRT.
A subset of 10 Group 1 patients (5 left-sided, 5 right-sided) will receive 13N-ammonia PET scans within the radiation simulation session.
A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.
Myocardial blood flow will be measured during rest and at peak stress with 13N-ammonia as a perfusion tracer.
A follow-up 13N-ammonia PET study with low-dose CT for attenuation correction will be obtained 12-18 months post-IMRT.
After
Physical examination by MD, Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.
Total length of the follow-up time will be 24 ± 2 months post-IMRT.
A subset of 10 left-sided patients will receive 13N-ammonia PET scans within the radiation simulation session.
A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.
Myocardial blood flow will be measured during rest and at peak stress with 13N-ammonia as a perfusion tracer.
A follow-up 13N-ammonia PET study with low-dose CT for attenuation correction will be obtained 12-18 months post-IMRT.
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 5
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Female age ≥ 18 years of age with a life expectancy estimated to be at least 2 years</li><li>Histologically-confirmed invasive breast cancer by MSKCC</li><li>Eastern Cooperative Oncology (ECOG) performance status of 0 or 1</li><li>Status post mastectomy with surgical assessment of axillary nodes</li><li>Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC</li><li>Will be receiving comprehensive PMRT, including the axillary, supraclavicular, and internal mammary nodes, at MSKCC</li></ul><p>Exclusion Criteria:</p><ul><li>Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)</li><li>Patients with nipple-sparing mastectomy</li><li>Patients receiving a chest wall boost</li><li>Pregnant or breastfeeding.</li><li>Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.</li><li>Prior radiation therapy to the ipsilateral breast&#x2F;nodes or thorax.</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Female age ≥ 18 years of age with a life expectancy estimated to be at least 2 years</li><li>Histologically-confirmed invasive breast cancer by MSKCC</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1</li><li>Status post mastectomy with surgical assessment of axillary nodes</li><li>Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC</li><li>Will be receiving comprehensive PMRT, including the axillary, supraclavicular, and internal mammary nodes, at MSKCC</li></ul><p>Exclusion Criteria:</p><ul><li>Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)</li><li>Patients with nipple-sparing mastectomy</li><li>Pregnant or breastfeeding.</li><li>Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.</li><li>Prior radiation therapy to the ipsilateral breast&#x2F;nodes or thorax.</li></ul>
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 5 ops
replace /protocolSection/contactsLocationsModule/locations/0/facility
Triage: Uncategorized
Uncategorized Operation 6
Before
Memorial Sloan-Kettering at Basking Ridge
After
Memorial Sloan Kettering at Basking Ridge
replace /protocolSection/contactsLocationsModule/locations/1/facility
Triage: Uncategorized
Uncategorized Operation 7
Before
Memorial Sloan-Kettering Cancer Center @ Suffolk
After
Memorial Sloan Kettering Cancer Center @ Suffolk
add /protocolSection/contactsLocationsModule/locations/2
Triage: Uncategorized
Uncategorized Operation 8
After
{
  "zip": "10604",
  "city": "East White Plains",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Alice Ho, MD",
      "role": "CONTACT",
      "phone": "212-639-6773"
    }
  ],
  "facility": "Memorial Sloan Kettering West Harrison",
  "geoPoint": {
    "lat": 41.03899,
    "lon": -73.74763
  }
}
replace /protocolSection/contactsLocationsModule/locations/4/facility
Triage: Uncategorized
Uncategorized Operation 9
Before
Memorial Sloan-Kettering at Mercy Medical Center
After
Memorial Sloan Kettering at Mercy Medical Center
replace /protocolSection/contactsLocationsModule/locations/5/facility
Triage: Uncategorized
Uncategorized Operation 10
Before
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
After
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
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
2014-08
After
2014-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2014-08-25
After
2014-10-23
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2014-08-26
After
2014-10-24
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2014-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2014-10-23"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2014-10-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "Physical examination by MD, Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-ammonia PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-ammonia as a perfusion tracer.\nA follow-up 13N-ammonia PET study with low-dose CT for attenuation correction will be obtained 12-18 months post-IMRT."
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Female age ≥ 18 years of age with a life expectancy estimated to be at least 2 years</li><li>Histologically-confirmed invasive breast cancer by MSKCC</li><li>Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1</li><li>Status post mastectomy with surgical assessment of axillary nodes</li><li>Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC</li><li>Will be receiving comprehensive PMRT, including the axillary, supraclavicular, and internal mammary nodes, at MSKCC</li></ul><p>Exclusion Criteria:</p><ul><li>Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)</li><li>Patients with nipple-sparing mastectomy</li><li>Pregnant or breastfeeding.</li><li>Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.</li><li>Prior radiation therapy to the ipsilateral breast&#x2F;nodes or thorax.</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/facility",
    "value": "Memorial Sloan Kettering at Basking Ridge"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/facility",
    "value": "Memorial Sloan Kettering Cancer Center @ Suffolk"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/2",
    "value": {
      "zip": "10604",
      "city": "East White Plains",
      "state": "New York",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Alice Ho, MD",
          "role": "CONTACT",
          "phone": "212-639-6773"
        }
      ],
      "facility": "Memorial Sloan Kettering West Harrison",
      "geoPoint": {
        "lat": 41.03899,
        "lon": -73.74763
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/facility",
    "value": "Memorial Sloan Kettering at Mercy Medical Center"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/facility",
    "value": "Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center"
  }
]