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NCT01147016

Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery

Version 11 to 12 · Barbara Ann Karmanos Cancer Institute

Patch inspector

Version 11 to 12

13 operations 3 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 19:13:29+00
Raw hash
8eaaeccb47bb9cbf7c6699f9df9c25b296324938f101d0d02c2fa593464a3de0
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 4 ops
replace /protocolSection/armsInterventionsModule/interventions/1/otherNames/0
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Cytoxan®¶
After
Cytoxan®
replace /protocolSection/armsInterventionsModule/interventions/2/otherNames/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Adriamycin®¶
After
Adriamycin®
replace /protocolSection/armsInterventionsModule/interventions/2/otherNames/1
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Rubex®¶
After
Rubex®
replace /protocolSection/armsInterventionsModule/interventions/6/description
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
As recommended by physician, post immunutherapy.
After
As recommended by physician, post immunotherapy.
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2013-04
After
2013-09
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2013-04-15
After
2013-09-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2013-04-17
After
2013-09-10
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 9
Before
<p>RATIONALE: Treating a patient&#x27;s T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body.
Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving combination chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.</p><p>PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.</p>
After
<p>RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery.
Arming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body.
Giving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.</p><p>PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.</p>
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 5 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery
After
Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery
replace /protocolSection/sponsorCollaboratorsModule/responsibleParty/type
Triage: Uncategorized
Uncategorized Operation 5
Before
SPONSOR
After
PRINCIPAL_INVESTIGATOR
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName
Triage: Uncategorized
Uncategorized Operation 6
After
Lawrence Lum
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle
Triage: Uncategorized
Uncategorized Operation 7
After
Principal Investigator
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorAffiliation
Triage: Uncategorized
Uncategorized Operation 8
After
Barbara Ann Karmanos Cancer Institute
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2013-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2013-09-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2013-09-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/type",
    "value": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
    "value": "Lawrence Lum"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
    "value": "Principal Investigator"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorAffiliation",
    "value": "Barbara Ann Karmanos Cancer Institute"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "<p>RATIONALE: Neoadjuvant chemotherapy for women with stage II-III Her negative breast cancer followed by Her2Bi armed activated T cells (ATCs) may significantly improve the pathologic complete response (pCR) rate at the time of surgery.\nArming ex vivo expanded T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body.\nGiving combination neoadjuvant chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.</p><p>PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after neoadjuvant chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0",
    "value": "Cytoxan®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames/0",
    "value": "Adriamycin®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames/1",
    "value": "Rubex®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/description",
    "value": "As recommended by physician, post immunotherapy."
  }
]