NCT02086578
Version 8 to 9 · Memorial Sloan Kettering Cancer Center
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arms_or_interventions_changeeligibility_criteria_changeenrollment_count_change [
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"path": "/protocolSection/designModule/enrollmentInfo/count",
"signal": "enrollment_count_change_ge_20pct",
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"severity": "high",
"new_value": 112,
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] 73385ead45846f80a64f9758004eae8477d8481c5c57b54716e5c2a24626cb90/protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 155
112
/protocolSection/armsInterventionsModule/armGroups/0/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Physical examination by MD, optional 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-NH3 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-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (+ 2 months) post-IMRT.
Physical examination by MD, optional 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-NH3 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-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.
/protocolSection/armsInterventionsModule/armGroups/1/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 5-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT
/protocolSection/eligibilityModule/eligibilityCriteria eligibility_criteria_change Eligibility criteria changes can alter the studied population. <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/nodes or thorax.</li></ul>
<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/nodes or thorax.</li><li>The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol</li></ul>
/protocolSection/statusModule/statusVerifiedDate 2016-01
2016-05
/protocolSection/statusModule/lastUpdateSubmitDate 2016-01-05
2016-05-20
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2016-01-06
2016-05-23
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"value": "Physical examination by MD, optional 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-NH3 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-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT."
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"value": "Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT"
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{
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"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/nodes or thorax.</li><li>The criterias outlined above apply to the patients enrolled to meet the primary objective of the study.\nAdditional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol</li></ul>"
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]