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 5 to 6 · Memorial Sloan Kettering Cancer Center

Patch inspector

Version 5 to 6

4 operations 2 path groups ctgov_internal_history

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

eligibility_criteria_change

Value signals

None recorded.

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 18:59:08+00
Raw hash: df3ceab36704752090724507159f427660dde289c57d7e945dc26fb0cc6a9ae1
Payload: Source URL

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 4

Matched rules

eligibility_criteria_change Eligibility criteria changes can alter the studied population.

Before

<p>Inclusion Criteria:</p><ul><li>Females who are 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>If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.</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>

After

<p>Inclusion Criteria:</p><ul><li>Females who are 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>If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.</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>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>

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

2015-05

After

2015-09

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 2

Before

2015-05-14

After

2015-09-17

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 3

Before

2015-05-15

After

2015-09-18

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2015-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-09-17"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-09-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Females who are 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>If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.</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>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>"
  }
]