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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 3e100ac660dab9ae84a024719410b89129caa719a5508826d1f5f31df13af0ef Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops replace /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High Arm Intervention Change Operation 5
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. 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 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. replace /protocolSection/armsInterventionsModule/interventions/2/description
Triage: High Arm Intervention Change Operation 6
Matched rules arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Before
Treatment will be delivered over approximately 5 weeks in 25 fractions, utilizing 6 MV photons.
A daily 3 mm bolus will be applied over the chest wall. After
The radiation dose (50-50.4
Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT. Eligibility Criteria and population definition changes. Triage: High 1 ops replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High Eligibility Change Operation 7
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>Inability to meet IMRT dose parameters for PTV (D95 of PTV ≥ 95% of prescription dose and D05 of PTV ≤ 110% of prescription dose) as specified in IRB # 10-025</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/nodes or thorax.</li><li>Must be able to undergo MRI</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 (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/nodes or thorax.</li></ul> Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized Uncategorized Operation 1
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized Uncategorized Operation 2
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized Uncategorized Operation 3
add /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized Uncategorized Operation 4
After
Patients will undergo mastectomy + axillary dissection with immediate tissue expander placement.
As is the current practice at our institution, patients who receive adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange.
Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment.
In these patients, exchange for the permanent implant will occur no sooner than 6 months ± 2 weeks following radiation. Raw JSON Patch [
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2014-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2014-08-25"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2014-08-26"
},
{
"op": "add",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "Patients will undergo mastectomy + axillary dissection with immediate tissue expander placement.\nAs is the current practice at our institution, patients who receive adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange.\nPatients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment.\nIn these patients, exchange for the permanent implant will occur no sooner than 6 months ± 2 weeks following radiation."
},
{
"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 Group 1 patients (5 left-sided, 5 right-sided) 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/armsInterventionsModule/interventions/2/description",
"value": "The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast 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 (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/nodes or thorax.</li></ul>"
}
]