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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 6 to 7 · Memorial Sloan Kettering Cancer Center

Patch inspector

Version 6 to 7

5 operations 2 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_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:08+00
Raw hash
21c525ae4e19d17546e570c9117860e1bde63ef6e31f4e3277c5f58d89f29f3a
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/armsInterventionsModule/armGroups/1/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, 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 no sooner than 6 (+ 2 weeks) months following the completion of radiation.
Total length of the follow-up time will be 30 ± 2 months post-IMRT
After
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
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2015-09
After
2015-11
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-09-17
After
2015-11-25
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2015-09-18
After
2015-11-26
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 4
Before
Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement.
As is the current practice at MSKCC, patients receiving 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.
After
Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement.
As is the current practice at MSKCC, patients receiving 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 at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2015-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-11-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-11-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement.\nAs is the current practice at MSKCC, patients receiving 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 at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
    "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 5-8 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"
  }
]