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NCT01142401

Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Version 4 to 5 · National Cancer Institute (NCI)

Patch inspector

Version 4 to 5

171 operations 8 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_changecontact_admin_changedesign_info_changeeligibility_criteria_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_earlier_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": null,
    "old_type": null,
    "severity": "low",
    "direction": "earlier",
    "new_value": "2010-05",
    "old_value": "2010-06",
    "delta_days": 31,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2014-06",
    "old_value": "2012-01",
    "delta_days": 882,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:08+00
Raw hash
583825ea7bda8cec3240e8f7b2190f65959dc9f17d9aa1a63cd681fb0363f7c6
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 3 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 47
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Clinical benefit rate in patients for at least 24 weeks
After
PFS
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 48
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
1.7 years for enrollment plus 1 year of follow-up
After
From first treatment day until objective or disease progression or death from any cause, assessed up to 4 years
add /protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Critical
Primary Outcome Change Operation 49
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
The PFS distributions of the two treatment arms will be estimated by Kaplan-Meier.
PFS distributions will be compared by an unstratified log-rank test.
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 19 ops
replace /protocolSection/designModule/designInfo/maskingInfo/masking
Triage: High
Design Change Operation 28
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
NONE
After
DOUBLE
add /protocolSection/designModule/designInfo/maskingInfo/whoMasked
Triage: High
Design Change Operation 29
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
[
  "PARTICIPANT",
  "INVESTIGATOR"
]
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 30
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm I
After
Arm I (fulvestrant)
replace /protocolSection/armsInterventionsModule/armGroups/0/type
Triage: High
Arm Intervention Change Operation 31
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
ACTIVE_COMPARATOR
After
EXPERIMENTAL
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: High
Arm Intervention Change Operation 32
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: laboratory biomarker analysis
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 33
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm II
After
Arm II (fulvestrant, bortezomib)
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 34
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: fulvestrant
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 35
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: fulvestrant
After
Other: laboratory biomarker analysis
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 36
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
bortezomib
After
fulvestrant
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 37
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given IV
After
Given intramuscularly
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 38
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm II
After
Arm I (fulvestrant)
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 39
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm II (fulvestrant, bortezomib)
add /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 40
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "Faslodex",
  "ICI 182,780"
]
replace /protocolSection/armsInterventionsModule/interventions/1/name
Triage: High
Arm Intervention Change Operation 41
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
fulvestrant
After
bortezomib
replace /protocolSection/armsInterventionsModule/interventions/1/description
Triage: High
Arm Intervention Change Operation 42
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given intramuscularly
After
Given IV
replace /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 43
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm I
After
Arm II (fulvestrant, bortezomib)
remove /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 44
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm II
add /protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
Arm Intervention Change Operation 45
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "LDP 341",
  "MLN341",
  "VELCADE"
]
add /protocolSection/armsInterventionsModule/interventions/2
Triage: High
Arm Intervention Change Operation 46
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "laboratory biomarker analysis",
  "type": "OTHER",
  "description": "Correlative studies",
  "armGroupLabels": [
    "Arm I (fulvestrant)",
    "Arm II (fulvestrant, bortezomib)"
  ]
}
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 60
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>DISEASE CHARACTERISTICS:</p><ul><li><p>Histologically or cytologically confirmed breast cancer</p><ul><li>Stage IV disease or inoperable locally advanced disease</li><li><p>Disease resistant to aromatase inhibitor (AI) (i.e., anastrazole, letrozole, or exemestane) in the adjuvant setting, and&#x2F;or disease progression after 1 or more AIs for metastatic disease</p><ul><li>Prior exposure to ≥ 1 AI regimen allowed</li><li>Prior tamoxifen allowed but not required</li></ul></li></ul></li><li>Measurable or non-measurable disease, or both</li><li>Estrogen receptor-positive disease</li><li>No known brain metastases</li><li><p>No rapidly progressive life-threatening metastases, including any of the following:</p><ul><li>Extensive hepatic involvement (&gt; 50% of the liver)</li><li>Symptomatic lymphangitic metastases</li><li>Brain or leptomeningeal involvement</li></ul></li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li><p>Postmenopausal, meeting 1 of the following:</p><ul><li>At least 12 months without spontaneous menstrual bleeding</li><li>Prior bilateral salpingo-oophorectomy with or without hysterectomy</li><li>Age ≥ 55 years with a prior hysterectomy with or without oophorectomy</li><li>Age &lt; 55 years with a prior hysterectomy without oophorectomy or unknown status with a documented follicle-stimulating hormone level in postmenopausal range within the past 4 weeks</li><li>Undergoing treatment with a gonadotropin releasing hormone analog (GnRH) to suppress ovarian function (e.g., goserelin 3.6 mg every 4 weeks)</li></ul></li><li>ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)</li><li>Life expectancy &gt; 3 months</li><li>WBC ≥ 3,000&#x2F;mm^3</li><li>ANC ≥ 1,500&#x2F;mm^3</li><li>Platelet count ≥ 100,000&#x2F;mm^3</li><li>Total bilirubin normal</li><li>AST and ALT ≤ 2.5 times upper limit of normal</li><li>Creatinine normal OR creatinine clearance ≥ 60 mL&#x2F;min</li><li>More than 5 years since prior invasive malignancy except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix</li><li>No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or fulvestrant</li><li><p>No uncontrolled intercurrent illness including, but not limited to, any of the following:</p><ul><li>Ongoing or active infection</li><li>Symptomatic congestive heart failure</li><li>Unstable angina pectoris</li><li>Cardiac arrhythmia</li><li>Psychiatric illness and&#x2F;or social situations that would limit compliance with study requirements</li></ul></li><li>No peripheral neuropathy ≥ grade 2</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li>See Disease Characteristics</li><li>One prior chemotherapy regimen for metastatic disease allowed</li><li>Prior bevacizumab allowed</li><li><p>At least 4 weeks since up to 2 doses of prior fulvestrant</p><ul><li>The interval between the first fulvestrant dose and registration must be ≤ 6 weeks</li></ul></li><li>More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C)</li><li>No prior bortezomib</li><li>No other concurrent investigational agents</li><li>No concurrent combination antiretroviral therapy for HIV-positive patients</li><li><p>No concurrent anticancer treatment except for the following:</p><ul><li>Bisphosphonates for bone metastases</li><li><p>GnRH analog allowed provided patient had progressive disease on a GnRH analog plus a selective estrogen-receptor modulator (SERM) or an AI</p><ul><li>SERM or AI must be discontinued</li></ul></li></ul></li><li>No concurrent over-the-counter remedy or herbal supplement (for patients randomized to bortezomib arm)</li><li>No other concurrent anticancer agents or therapies</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>ELIGIBILITY CRITERIA FOR ARM A AND ARM B</li><li>Patients must have histologically or cytologically confirmed ER+ positive breast cancer</li><li>Patients must be postmenopausal, defined as: (1) a history of at least 12 months without spontaneous menstrual bleeding, (2) prior bilateral salpingo-oophorectomy, with or without hysterectomy, (3) age &gt;= 55 years with a prior hysterectomy with or without oophorectomy, (4) age &lt; 55 years with a prior hysterectomy without oophorectomy or unknown status, with a documented FSH level in postmenopausal range within 4 week s of registration, (5) receiving a gonadotropin releasing hormone analog (GnRH) to suppress ovarian function (eg, goserelin 3.6 mg q 4 weeks)</li><li>Patients must have stage IV disease or inoperable locally advanced disease</li><li>Patients may have measurable disease only, non-measurable disease only, or both (RECIST 1.1); it is anticipated that at least 50% of patients will have only non-measurable disease</li><li>Patients are required to have disease that is resistant to aromatase inhibitor (AI), which is defined either as relapse while receiving adjuvant A.I. therapy (ie, anastrazole, letrozole, or exemestane), and&#x2F;or disease progression after one or more A.I.s for metastatic disease; prior exposure to more than one AI is permitted</li><li>Patient may have had prior tamoxifen but are not required to</li><li>Patients may have received up to one prior chemotherapy regimen for metastatic disease</li><li>Patients may have received prior bevacizumab</li><li>Patients who have received up to 2 doses of fulvestrant given within a 4 week period prior to registration are eligible; the interval between the first fulvestrant dose and registration must be 6 weeks or less; patients may have received EITHER 250 mg or 500 mg of fulvestrant previously; if the patient has received 250 mg, they will receive the 500 mg loading dose on study day -14; if they already received 500 mg, they will begin the study on day +1</li><li>Life expectancy of greater than 3 months</li><li>ECOG performance status =&lt; 2 (Karnofsky &gt;= 60%)</li><li>Leukocytes &gt;= 3,000&#x2F;mcL</li><li>Absolute neutrophil count &gt;= 1,500&#x2F;mcL</li><li>Platelets &gt;= 100,000&#x2F;mcL</li><li>Total bilirubin within normal institutional limits</li><li>AST(SGOT)&#x2F;ALT(SGPT) =&lt; 2.5 x institutional upper limit of normal</li><li>Creatinine within normal institutional limits OR</li><li>Creatinine clearance &gt;= 60 mL&#x2F;min&#x2F;1.73
m^2 for patients with creatinine levels above institutional normal</li><li>Patients must be disease-free of prior invasive malignancies for &gt;= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix</li><li>Patients must have the ability to understand and the willingness to sign a written informed consent document</li><li>The effects of bortezomib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately</li><li>ELIGIBILITY CRITERIA FOR ARM C</li><li>Previously met all eligibility criteria for arms A and B and registered on trial to arm A (fulvestrant alone)</li><li>Disease progression on arm A and agreeable to crossover to arm C</li><li>Has received no intervening therapy (ie, alternative endocrine therapy, chemotherapy, biologic therapy) between disease progression on arm A and registration an arm C</li><li>ECOG performance status 0-2</li><li>Tumor measurements (eg, CT scan of chest&#x2F;abdomen&#x2F;pelvis) within 4 weeks of registration to arm C</li><li><p>Normal organ and marrow function as defined below (within 2 weeks of registration on arm C):</p><ul><li>Leukocytes &gt;= 3,000&#x2F;mcL</li><li>Absolute neutrophil count &gt;= 1,500&#x2F;mcL</li><li>Platelets &gt;= 100,000&#x2F;mcL</li><li>Total bilirubin within normal institutional limits</li><li>AST(SGOT)&#x2F;ALT(SGPT) =&lt; 2.5 x institutional upper limit of normal</li><li>Creatinine within normal institutional limits OR</li><li>Creatinine clearance &gt;= 60 mL&#x2F;min&#x2F;1.73
m^2 for patients with creatinine levels above institutional normal</li></ul></li></ul><p>Exclusion Criteria:</p><ul><li>EXCLUSION CRITERIA FOR ARM A AND ARM B</li><li>Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier</li><li>Patients may not be receiving any other investigational agents</li><li>Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events</li><li>Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (&gt; 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement</li><li>History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or fulvestrant</li><li>Patients who are concomitantly receiving bortezomib and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy</li><li>Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements</li><li>HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with bortezomib; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated</li><li>Patients who have previously received fulvestrant</li><li>Patients who have previously received bortezomib</li><li>Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued</li><li>Grade 2 or more peripheral neuropathy because the dose limiting toxicity of bortezomib is neuropathy</li></ul>
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 10 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 50
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Progression-free survival at 24 weeks
After
Clinical benefit rate (CBR) (CR, PR, or SD)
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 51
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
1.7 years for enrollment plus 1 year of follow-up
After
Up to 24 weeks
add /protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
Secondary Outcome Change Operation 52
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Ninety-five percent confidence intervals will be calculated for the clinical benefit response proportion in each arm via binomial proportions.
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 53
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall survival
After
Percentage of progression-free
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 54
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
1.7 years for enrollment plus 1 year of follow-up
After
Up to 24 weeks
add /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 55
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Ninety-five percent confidence intervals will be calculated for the percent progression-free at 24 weeks in each arm via binomial proportions
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 56
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Clinical benefit rate at 12 and 24 weeks in patients who crossover from fulvestrant alone to the combination treatment
After
Overall response rate
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 57
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
1.7 years for enrollment plus 1 year of follow-up
After
From first treatment day until death, assessed up to 4 years
add /protocolSection/outcomesModule/secondaryOutcomes/2/description
Triage: High
Secondary Outcome Change Operation 58
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Using Kaplan-Meier method.
add /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 59
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Toxicity as assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0",
  "timeFrame": "Up to 4 years"
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 9
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2010-06
After
2010-05
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 10
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2012-01
After
2014-06
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 111 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 61
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Kerin Adelson, MD",
    "role": "CONTACT",
    "email": "kerin.adelson@mssm.edu",
    "phone": "212-241-2299"
  },
  {
    "name": "Joseph Sparano, MD",
    "role": "CONTACT",
    "email": "jsparano@montefiore.org",
    "phone": "718-904-2555"
  }
]
replace /protocolSection/contactsLocationsModule/overallOfficials/0/name
Triage: Uncategorized
Uncategorized Operation 62
Before
Kerin Adelson, MD
After
Kerin Adelson
replace /protocolSection/contactsLocationsModule/overallOfficials/0/affiliation
Triage: Uncategorized
Uncategorized Operation 63
Before
Tisch Cancer Institute at Mount Sinai School of Medicine
After
Montefiore Medical Center
replace /protocolSection/contactsLocationsModule/locations/0/facility
Triage: Uncategorized
Uncategorized Operation 64
Before
University of Connecticut Health Center
After
University of Connecticut
replace /protocolSection/contactsLocationsModule/locations/0/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 65
Before
Susan Tannenbaum, MD
After
Susan H. Tannenbaum
replace /protocolSection/contactsLocationsModule/locations/0/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 66
Before
860-679-2474
After
800-579-7822
replace /protocolSection/contactsLocationsModule/locations/0/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 67
Before
Susan Tannenbaum, MD
After
Susan H. Tannenbaum
replace /protocolSection/contactsLocationsModule/locations/1/facility
Triage: Uncategorized
Uncategorized Operation 68
Before
Maimonides Cancer Center
After
Yale University
replace /protocolSection/contactsLocationsModule/locations/1/city
Triage: Uncategorized
Uncategorized Operation 69
Before
Brooklyn
After
New Haven
replace /protocolSection/contactsLocationsModule/locations/1/state
Triage: Uncategorized
Uncategorized Operation 70
Before
New York
After
Connecticut
replace /protocolSection/contactsLocationsModule/locations/1/zip
Triage: Uncategorized
Uncategorized Operation 71
Before
11220
After
06520-8032
replace /protocolSection/contactsLocationsModule/locations/1/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 72
Before
Susan Burdette-Radoux, MD
After
Gina G. Chung
replace /protocolSection/contactsLocationsModule/locations/1/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 73
Before
718-765-2644
After
203-785-5702
replace /protocolSection/contactsLocationsModule/locations/1/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 74
Before
sburdette-radoux@maimonides.org
After
gina.chung@yale.edu
replace /protocolSection/contactsLocationsModule/locations/1/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 75
Before
Susan Burdette-Radoux, MD
After
Gina G. Chung
remove /protocolSection/contactsLocationsModule/locations/1/contacts/2
Triage: Uncategorized
Uncategorized Operation 76
Before
{
  "name": "Alan Astrow, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/1/contacts/2
Triage: Uncategorized
Uncategorized Operation 77
Before
{
  "name": "William Solomon, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/1/contacts/2
Triage: Uncategorized
Uncategorized Operation 78
Before
{
  "name": "Yiqing Xu, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/1/contacts/2
Triage: Uncategorized
Uncategorized Operation 79
Before
{
  "name": "Lech Dabrowski, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/1/contacts/2
Triage: Uncategorized
Uncategorized Operation 80
Before
{
  "name": "Philip Rubin, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 81
Before
40.6501
After
41.30815
replace /protocolSection/contactsLocationsModule/locations/1/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 82
Before
-73.94958
After
-72.92816
replace /protocolSection/contactsLocationsModule/locations/2/facility
Triage: Uncategorized
Uncategorized Operation 83
Before
New York University
After
Washington University School of Medicine
replace /protocolSection/contactsLocationsModule/locations/2/city
Triage: Uncategorized
Uncategorized Operation 84
Before
New York
After
St Louis
replace /protocolSection/contactsLocationsModule/locations/2/state
Triage: Uncategorized
Uncategorized Operation 85
Before
New York
After
Missouri
replace /protocolSection/contactsLocationsModule/locations/2/zip
Triage: Uncategorized
Uncategorized Operation 86
Before
10016
After
63110
replace /protocolSection/contactsLocationsModule/locations/2/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 87
Before
Yelena Novik, MD
After
Tanya M. Wildes
replace /protocolSection/contactsLocationsModule/locations/2/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 88
Before
212-731-5350
After
800-600-3606
replace /protocolSection/contactsLocationsModule/locations/2/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 89
Before
yelena.novik@nyumc.org
After
info@siteman.wustl.edu
replace /protocolSection/contactsLocationsModule/locations/2/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 90
Before
Yelena Novik, MD
After
Tanya M. Wildes
remove /protocolSection/contactsLocationsModule/locations/2/contacts/2
Triage: Uncategorized
Uncategorized Operation 91
Before
{
  "name": "Franco Muggia, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/2/contacts/2
Triage: Uncategorized
Uncategorized Operation 92
Before
{
  "name": "James Speyer, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/2/contacts/2
Triage: Uncategorized
Uncategorized Operation 93
Before
{
  "name": "Amy Tierste, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/2/contacts/2
Triage: Uncategorized
Uncategorized Operation 94
Before
{
  "name": "Matthew Volm, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/2/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 95
Before
40.71427
After
38.62727
replace /protocolSection/contactsLocationsModule/locations/2/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 96
Before
-74.00597
After
-90.19789
replace /protocolSection/contactsLocationsModule/locations/3/facility
Triage: Uncategorized
Uncategorized Operation 97
Before
Weill Medical College- Cornell
After
Cancer Institute of New Jersey
replace /protocolSection/contactsLocationsModule/locations/3/city
Triage: Uncategorized
Uncategorized Operation 98
Before
New York
After
New Brunswick
replace /protocolSection/contactsLocationsModule/locations/3/state
Triage: Uncategorized
Uncategorized Operation 99
Before
New York
After
New Jersey
replace /protocolSection/contactsLocationsModule/locations/3/zip
Triage: Uncategorized
Uncategorized Operation 100
Before
10021
After
08903
replace /protocolSection/contactsLocationsModule/locations/3/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 101
Before
Tessa Cigler, MD
After
Serena T. Wong
replace /protocolSection/contactsLocationsModule/locations/3/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 102
Before
212-821-0644
After
732-235-8675
add /protocolSection/contactsLocationsModule/locations/3/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 103
After
wongse@umdnj.edu
replace /protocolSection/contactsLocationsModule/locations/3/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 104
Before
Tessa Cigler, MD
After
Serena T. Wong
remove /protocolSection/contactsLocationsModule/locations/3/contacts/2
Triage: Uncategorized
Uncategorized Operation 105
Before
{
  "name": "Linda Vahdat, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/3/contacts/2
Triage: Uncategorized
Uncategorized Operation 106
Before
{
  "name": "Ellen Chuang",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 107
Before
40.71427
After
40.48622
replace /protocolSection/contactsLocationsModule/locations/3/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 108
Before
-74.00597
After
-74.45182
replace /protocolSection/contactsLocationsModule/locations/4/facility
Triage: Uncategorized
Uncategorized Operation 109
Before
Tisch Cancer Center- Mount Sinai School of Medicine
After
Maimonides Medical Center
replace /protocolSection/contactsLocationsModule/locations/4/city
Triage: Uncategorized
Uncategorized Operation 110
Before
New York
After
Brooklyn
replace /protocolSection/contactsLocationsModule/locations/4/zip
Triage: Uncategorized
Uncategorized Operation 111
Before
10029
After
11219
replace /protocolSection/contactsLocationsModule/locations/4/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 112
Before
Kerin Adelson, MD
After
Yiqing Xu
replace /protocolSection/contactsLocationsModule/locations/4/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 113
Before
212-241-2299
After
718-765-2600
replace /protocolSection/contactsLocationsModule/locations/4/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 114
Before
kerin.adelson@mssm.edu
After
YXu@maimonidesmed.org
replace /protocolSection/contactsLocationsModule/locations/4/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 115
Before
Kerin Adelson, MD
After
Yiqing Xu
remove /protocolSection/contactsLocationsModule/locations/4/contacts/2
Triage: Uncategorized
Uncategorized Operation 116
Before
{
  "name": "George Raptis, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/4/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 117
Before
40.71427
After
40.6501
replace /protocolSection/contactsLocationsModule/locations/4/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 118
Before
-74.00597
After
-73.94958
replace /protocolSection/contactsLocationsModule/locations/5/facility
Triage: Uncategorized
Uncategorized Operation 119
Before
Columbia Presbyterian Medical Center
After
Maimonides Cancer Center-Breast Cancer Program
replace /protocolSection/contactsLocationsModule/locations/5/city
Triage: Uncategorized
Uncategorized Operation 120
Before
New York
After
Brooklyn
replace /protocolSection/contactsLocationsModule/locations/5/zip
Triage: Uncategorized
Uncategorized Operation 121
Before
10031
After
11220
replace /protocolSection/contactsLocationsModule/locations/5/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 122
Before
Dawn Hershman, MD
After
Philip Rubin
replace /protocolSection/contactsLocationsModule/locations/5/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 123
Before
212-305-1945
After
718-765-2600
replace /protocolSection/contactsLocationsModule/locations/5/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 124
Before
dlh23@columbia.edu
After
prubin@maimonidesmed.org
replace /protocolSection/contactsLocationsModule/locations/5/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 125
Before
Susan Refice
After
Philip Rubin
replace /protocolSection/contactsLocationsModule/locations/5/contacts/1/role
Triage: Uncategorized
Uncategorized Operation 126
Before
CONTACT
After
PRINCIPAL_INVESTIGATOR
remove /protocolSection/contactsLocationsModule/locations/5/contacts/1/phone
Triage: Uncategorized
Uncategorized Operation 127
Before
212-305-0176
remove /protocolSection/contactsLocationsModule/locations/5/contacts/2
Triage: Uncategorized
Uncategorized Operation 128
Before
{
  "name": "Dawn Hershman, MD",
  "role": "PRINCIPAL_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/5/contacts/2
Triage: Uncategorized
Uncategorized Operation 129
Before
{
  "name": "Karen Crew, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/5/contacts/2
Triage: Uncategorized
Uncategorized Operation 130
Before
{
  "name": "Kevin Kalinsky, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 131
Before
40.71427
After
40.6501
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 132
Before
-74.00597
After
-73.94958
replace /protocolSection/contactsLocationsModule/locations/6/facility
Triage: Uncategorized
Uncategorized Operation 133
Before
Montefiore Medical Center
After
Roswell Park Cancer Institute
replace /protocolSection/contactsLocationsModule/locations/6/city
Triage: Uncategorized
Uncategorized Operation 134
Before
The Bronx
After
Buffalo
replace /protocolSection/contactsLocationsModule/locations/6/zip
Triage: Uncategorized
Uncategorized Operation 135
Before
10461
After
14263
replace /protocolSection/contactsLocationsModule/locations/6/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 136
Before
Joseph Sparano, MD
After
Foluso O. Ademuyiwa
replace /protocolSection/contactsLocationsModule/locations/6/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 137
Before
718-904-2555
After
877-275-7724
replace /protocolSection/contactsLocationsModule/locations/6/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 138
Before
jsparano@montefiore.org
After
foluso.ademuyiwa@roswellpark.org
replace /protocolSection/contactsLocationsModule/locations/6/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 139
Before
Lisa Escobar
After
Foluso O. Ademuyiwa
replace /protocolSection/contactsLocationsModule/locations/6/contacts/1/role
Triage: Uncategorized
Uncategorized Operation 140
Before
CONTACT
After
PRINCIPAL_INVESTIGATOR
remove /protocolSection/contactsLocationsModule/locations/6/contacts/1/phone
Triage: Uncategorized
Uncategorized Operation 141
Before
718-904-2730
remove /protocolSection/contactsLocationsModule/locations/6/contacts/1/email
Triage: Uncategorized
Uncategorized Operation 142
Before
lescobar@montefiore.org
remove /protocolSection/contactsLocationsModule/locations/6/contacts/2
Triage: Uncategorized
Uncategorized Operation 143
Before
{
  "name": "Joseph Sparano, MD",
  "role": "PRINCIPAL_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/6/contacts/2
Triage: Uncategorized
Uncategorized Operation 144
Before
{
  "name": "Christine Pellegrino, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/6/contacts/2
Triage: Uncategorized
Uncategorized Operation 145
Before
{
  "name": "Petra Rietschel, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/6/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 146
Before
40.84985
After
42.88645
replace /protocolSection/contactsLocationsModule/locations/6/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 147
Before
-73.86641
After
-78.87837
replace /protocolSection/contactsLocationsModule/locations/7/facility
Triage: Uncategorized
Uncategorized Operation 148
Before
Ohio State University
After
Beth Israel Medical Center
replace /protocolSection/contactsLocationsModule/locations/7/city
Triage: Uncategorized
Uncategorized Operation 149
Before
Columbus
After
New York
replace /protocolSection/contactsLocationsModule/locations/7/state
Triage: Uncategorized
Uncategorized Operation 150
Before
Ohio
After
New York
replace /protocolSection/contactsLocationsModule/locations/7/zip
Triage: Uncategorized
Uncategorized Operation 151
Before
43210
After
10003
replace /protocolSection/contactsLocationsModule/locations/7/contacts/0/name
Triage: Uncategorized
Uncategorized Operation 152
Before
Bhuvaneswari Ramaswamy, MD
After
Theresa Shao
replace /protocolSection/contactsLocationsModule/locations/7/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 153
Before
614-293-6401
After
212-367-1729
replace /protocolSection/contactsLocationsModule/locations/7/contacts/0/email
Triage: Uncategorized
Uncategorized Operation 154
Before
bhuvaneswar.ramaswamy@osumc.edu
After
tshao@chpnet.org
replace /protocolSection/contactsLocationsModule/locations/7/contacts/1/name
Triage: Uncategorized
Uncategorized Operation 155
Before
Bhuvaneswari Ramaswamy, MD
After
Theresa Shao
remove /protocolSection/contactsLocationsModule/locations/7/contacts/2
Triage: Uncategorized
Uncategorized Operation 156
Before
{
  "name": "Kari Kendra, MD",
  "role": "SUB_INVESTIGATOR"
}
remove /protocolSection/contactsLocationsModule/locations/7/contacts/2
Triage: Uncategorized
Uncategorized Operation 157
Before
{
  "name": "Ewa Mrozek, MD",
  "role": "SUB_INVESTIGATOR"
}
replace /protocolSection/contactsLocationsModule/locations/7/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 158
Before
39.96118
After
40.71427
replace /protocolSection/contactsLocationsModule/locations/7/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 159
Before
-82.99879
After
-74.00597
add /protocolSection/contactsLocationsModule/locations/8
Triage: Uncategorized
Uncategorized Operation 160
After
{
  "zip": "10016-4760",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Linda T. Vahdat",
      "role": "CONTACT",
      "email": "ltv2001@med.cornell.edu",
      "phone": "212-746-1848"
    },
    {
      "name": "Linda T. Vahdat",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "New York University Clinical Cancer Center",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/9
Triage: Uncategorized
Uncategorized Operation 161
After
{
  "zip": "10016",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Tibor Moskovits",
      "role": "CONTACT",
      "email": "tibor.moskovits@nyumc.org",
      "phone": "212-731-5191"
    },
    {
      "name": "Tibor Moskovits",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "New York University Langone Medical Center",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/10
Triage: Uncategorized
Uncategorized Operation 162
After
{
  "zip": "10019",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Anupama Goel",
      "role": "CONTACT",
      "email": "agoel@chpnet.org",
      "phone": "212-523-6769"
    },
    {
      "name": "Anupama Goel",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Saint Luke&#x27;s Roosevelt Hospital Center - Roosevelt Division",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/11
Triage: Uncategorized
Uncategorized Operation 163
After
{
  "zip": "10029",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "George Raptis",
      "role": "CONTACT",
      "email": "jenny.figueroa@mssm.edu",
      "phone": "212-824-7320"
    },
    {
      "name": "George Raptis",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Mount Sinai Medical Center",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 164
After
{
  "zip": "10032",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Kevin M. Kalinsky",
      "role": "CONTACT",
      "email": "kk2693@columbia.edu",
      "phone": "212-305-8615"
    },
    {
      "name": "Kevin M. Kalinsky",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Columbia University Medical Center",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/13
Triage: Uncategorized
Uncategorized Operation 165
After
{
  "zip": "10065",
  "city": "New York",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Tessa Cigler",
      "role": "CONTACT",
      "email": "tec9002@med.cornell.edu",
      "phone": "212-821-0644"
    },
    {
      "name": "Tessa Cigler",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Weill Medical College of Cornell University",
  "geoPoint": {
    "lat": 40.71427,
    "lon": -74.00597
  }
}
add /protocolSection/contactsLocationsModule/locations/14
Triage: Uncategorized
Uncategorized Operation 166
After
{
  "zip": "10461",
  "city": "The Bronx",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Della F. Makower",
      "role": "CONTACT",
      "email": "aecc@aecom.yu.edu",
      "phone": "718-904-2730"
    },
    {
      "name": "Della F. Makower",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Montefiore Medical Center-Weiler Division",
  "geoPoint": {
    "lat": 40.84985,
    "lon": -73.86641
  }
}
add /protocolSection/contactsLocationsModule/locations/15
Triage: Uncategorized
Uncategorized Operation 167
After
{
  "zip": "10466",
  "city": "The Bronx",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Eleni Andreopoulou",
      "role": "CONTACT",
      "email": "aecc@aecom.yu.edu",
      "phone": "718-904-2730"
    },
    {
      "name": "Eleni Andreopoulou",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "The North Division of Montefiore Medical Center",
  "geoPoint": {
    "lat": 40.84985,
    "lon": -73.86641
  }
}
add /protocolSection/contactsLocationsModule/locations/16
Triage: Uncategorized
Uncategorized Operation 168
After
{
  "zip": "10469",
  "city": "The Bronx",
  "state": "New York",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Avi S. Retter",
      "role": "CONTACT",
      "email": "retter@eastchestercenter.com",
      "phone": "718-732-4000"
    },
    {
      "name": "Avi S. Retter",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Eastchester Center for Cancer Care",
  "geoPoint": {
    "lat": 40.84985,
    "lon": -73.86641
  }
}
add /protocolSection/contactsLocationsModule/locations/17
Triage: Uncategorized
Uncategorized Operation 169
After
{
  "zip": "44106",
  "city": "Cleveland",
  "state": "Ohio",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Lois J. Teston",
      "role": "CONTACT",
      "email": "lteston@pol.net",
      "phone": "216-844-1374"
    },
    {
      "name": "Lois J. Teston",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Case Western Reserve University",
  "geoPoint": {
    "lat": 41.4995,
    "lon": -81.69541
  }
}
add /protocolSection/contactsLocationsModule/locations/18
Triage: Uncategorized
Uncategorized Operation 170
After
{
  "zip": "44195",
  "city": "Cleveland",
  "state": "Ohio",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Marc A. Shapiro",
      "role": "CONTACT",
      "email": "shapirm@ccf.org",
      "phone": "866-223-8100"
    },
    {
      "name": "Marc A. Shapiro",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Cleveland Clinic Foundation",
  "geoPoint": {
    "lat": 41.4995,
    "lon": -81.69541
  }
}
add /protocolSection/contactsLocationsModule/locations/19
Triage: Uncategorized
Uncategorized Operation 171
After
{
  "zip": "43210",
  "city": "Columbus",
  "state": "Ohio",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Kari L. Kendra",
      "role": "CONTACT",
      "email": "osu@emergingmed.com",
      "phone": "866-627-7616"
    },
    {
      "name": "Kari L. Kendra",
      "role": "PRINCIPAL_INVESTIGATOR"
    }
  ],
  "facility": "Ohio State University Medical Center",
  "geoPoint": {
    "lat": 39.96118,
    "lon": -82.99879
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 11 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 8
Before
2011-03
After
2013-05
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 11
Before
2011-03-17
After
2013-05-15
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
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2011-03-21
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2013-05-16
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<p>RATIONALE: Estrogen can cause the growth of breast cancer cells.
Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes.
Bortezomib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
It is not yet known whether fulvestrant is more effective with or without bortezomib in treating breast cancer.</p><p>PURPOSE: This phase II trial is studying giving fulvestrant and bortezomib together to see how well they work compared to fulvestrant alone in treating postmenopausal women with locally advanced or metastatic breast cancer.</p>
After
This phase II trial is studying giving fulvestrant and bortezomib together to see how well they work compared to fulvestrant alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
Estrogen can cause the growth of breast cancer cells.
Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes.
Bortezomib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
It is not yet known whether fulvestrant is more effective with or without bortezomib in treating breast cancer.
replace /protocolSection/descriptionModule/detailedDescription
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<p>OBJECTIVES:</p><p>Primary</p><ul><li>To determine the median progression-free survival of postmenopausal women with locally advanced or metastatic estrogen receptor (ER)-positive breast cancer treated with fulvestrant with versus without bortezomib.</li></ul><p>Secondary</p><ul><li>To determine whether the addition of bortezomib to fulvestrant improves the clinical benefit rate of these patients for at least 24 weeks.</li><li>To determine the progression-free survival at 24 weeks of patients treated with these regimens.</li><li>To determine the overall survival of patients treated with these regimens.</li><li>To determine the adverse event profile of these regimens in these patients.</li><li>To determine the clinical benefit rate at 12 and 24 weeks of patients who progressed on fulvestrant alone and crossed over to the combination treatment.</li></ul><p>Tertiary</p><ul><li>To analyze the effects of bortezomib and fulvestrant in intratumoral nuclear&#x2F;cytoplasmic ER ratio, unfolded protein response (BiP), apoptosis (cleaved caspase 3, Bcl-2 phospho JNK) in tumors accessible to biopsy.
(Exploratory)</li><li>To determine whether activation of NF-kB correlates with a poor response to fulvestrant alone and with low levels of the markers of apoptosis.
(Exploratory)</li><li>To determine whether cyclin D1 expression in pretreatment tumor specimens (metastatic disease or the primary tumor) is predictive of clinical benefit with fulvestrant-bortezomib. (Exploratory)</li></ul><p>OUTLINE: This is a multicenter study.
Patients are stratified according to ECOG performance status (0 vs 1-2), measurable disease (yes vs no), and prior chemotherapy for metastatic disease (yes vs no).
Patients are randomized to 1 of 2 treatment arms.</p><ul><li>Arm I: Patients receive fulvestrant intramuscularly on day 1 (days -14, 1, and 15 of course 1 only).
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with progressive disease may crossover to arm II.</li><li>Arm II: Patients receive fulvestrant as in arm I and bortezomib IV on days 1, 8, and 15 (beginning in course 2).
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</li></ul><p>Some patients undergo blood and tumor tissue sample collection at baseline and during study for correlative studies.</p><p>After completion of study therapy, patients are followed up every 3 months.</p>
After
<p>PRIMARY OBJECTIVES:</p><p>I. To determine if the addition of bortezomib to fulvestrant improves median progression free survival (PFS) compared with fulvestrant alone in postmenopausal women with ER-positive locally advanced inoperable or metastatic breast cancer who have disease that is resistant to aromatase inhibitor therapy (Arms A vs. B).</p><p>SECONDARY OBJECTIVES:</p><p>I. To determine if the addition of bortezomib to fulvestrant improves the clinical benefit rate (defined as objective response plus stable disease for at least 24 weeks from day+1).</p><p>II.
To determine the percent of patients, treated with fulvestrant alone and fulvestrant plus bortezomib, who remain progression-free 24 weeks from day+1 (Arms A vs. B).</p><p>III.
To determine the overall survival of patients treated with fulvestrant alone and fulvestrant plus bortezomib.
(Arms A, B, C).</p><p>IV.
To determine the adverse event profile in patients treated with fulvestrant alone and fulvestrant plus bortezomib (Arms A, B, C).</p><p>V. To determine the clinical benefit rate at 12 and 24 weeks of fulvestrant plus bortezomib in patients who have progressed on the fulvestrant alone arm and crossover to receive the combination (Arm C).</p><p>TERTIARY OBJECTIVES:</p><p>I. To perform an exploratory analysis of the effects of bortezomib (plus fulvestrant) in intratumoral nuclear&#x2F;cytoplasmic ER ratio, unfolded protein response (BiP), apoptotis (cleaved caspase 3, Bcl-2 phospho JNK in patients with tumors accessible to biopsy who consent to optional post-treatment biopsy.</p><p>II.
To determine with cyclin D1 expression in pretreatment tumor specimens (from metastatic disease or the primary tumor if the former is not available) is predictive of clinical benefit with fulvestrant-bortezomib.</p><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>Arm I: Patients receive fulvestrant intramuscularly on day 1 (days -14, 1, and 15 of course 1 only).
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients with progressive disease may crossover to arm II.</p><p>Arm II: Patients receive fulvestrant as in arm I and bortezomib IV on days 1, 8, and 15 (beginning in course 2).
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study therapy, patients are followed up every 3 months.</p>
replace /protocolSection/conditionsModule/conditions/0
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Breast Cancer
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Estrogen Receptor-positive Breast Cancer
add /protocolSection/conditionsModule/conditions/1
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Stage III Breast Cancer
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Stage IIIB Breast Cancer
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Stage IIIC Breast Cancer
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Stage IV Breast Cancer
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Before
[
  "estrogen receptor-positive breast cancer",
  "stage IIIB breast cancer",
  "stage IIIC breast cancer",
  "stage IV breast cancer"
]
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 14 ops
replace /protocolSection/identificationModule/orgStudyIdInfo/id
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CDR0000674542
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NCI-2012-03000
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{
  "id": "10-03-055"
}
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{
  "id": "CDR0000674542"
}
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{
  "id": "N01CM00099",
  "link": "https:&#x2F;&#x2F;reporter.nih.gov&#x2F;quickSearch&#x2F;N01CM00099",
  "type": "NIH"
}
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{
  "id": "N01CM00070",
  "link": "https:&#x2F;&#x2F;reporter.nih.gov&#x2F;quickSearch&#x2F;N01CM00070",
  "type": "NIH"
}
replace /protocolSection/identificationModule/organization/fullName
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Montefiore Medical Center
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National Cancer Institute (NCI)
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OTHER
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NIH
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Kerin Adelson
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Tisch Cancer Institute at Mount Sinai School of Medicine
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SPONSOR
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Montefiore Medical Center
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National Cancer Institute (NCI)
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OTHER
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NIH
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[
  {
    "name": "National Cancer Institute (NCI)",
    "class": "NIH"
  }
]
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{
  "oversightHasDmc": true
}
Raw JSON Patch
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    "path": "/protocolSection/identificationModule/orgStudyIdInfo/id",
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    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2013-05"
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    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This phase II trial is studying giving fulvestrant and bortezomib together to see how well they work compared to fulvestrant alone in treating postmenopausal women with locally advanced or metastatic breast cancer.\nEstrogen can cause the growth of breast cancer cells.\nHormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes.\nBortezomib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.\nIt is not yet known whether fulvestrant is more effective with or without bortezomib in treating breast cancer."
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>PRIMARY OBJECTIVES:</p><p>I. To determine if the addition of bortezomib to fulvestrant improves median progression free survival (PFS) compared with fulvestrant alone in postmenopausal women with ER-positive locally advanced inoperable or metastatic breast cancer who have disease that is resistant to aromatase inhibitor therapy (Arms A vs. B).</p><p>SECONDARY OBJECTIVES:</p><p>I. To determine if the addition of bortezomib to fulvestrant improves the clinical benefit rate (defined as objective response plus stable disease for at least 24 weeks from day+1).</p><p>II.\nTo determine the percent of patients, treated with fulvestrant alone and fulvestrant plus bortezomib, who remain progression-free 24 weeks from day+1 (Arms A vs. B).</p><p>III.\nTo determine the overall survival of patients treated with fulvestrant alone and fulvestrant plus bortezomib.\n(Arms A, B, C).</p><p>IV.\nTo determine the adverse event profile in patients treated with fulvestrant alone and fulvestrant plus bortezomib (Arms A, B, C).</p><p>V. To determine the clinical benefit rate at 12 and 24 weeks of fulvestrant plus bortezomib in patients who have progressed on the fulvestrant alone arm and crossover to receive the combination (Arm C).</p><p>TERTIARY OBJECTIVES:</p><p>I. To perform an exploratory analysis of the effects of bortezomib (plus fulvestrant) in intratumoral nuclear&#x2F;cytoplasmic ER ratio, unfolded protein response (BiP), apoptotis (cleaved caspase 3, Bcl-2 phospho JNK in patients with tumors accessible to biopsy who consent to optional post-treatment biopsy.</p><p>II.\nTo determine with cyclin D1 expression in pretreatment tumor specimens (from metastatic disease or the primary tumor if the former is not available) is predictive of clinical benefit with fulvestrant-bortezomib.</p><p>OUTLINE: Patients are randomized to 1 of 2 treatment arms.</p><p>Arm I: Patients receive fulvestrant intramuscularly on day 1 (days -14, 1, and 15 of course 1 only).\nCourses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\nPatients with progressive disease may crossover to arm II.</p><p>Arm II: Patients receive fulvestrant as in arm I and bortezomib IV on days 1, 8, and 15 (beginning in course 2).\nCourses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</p><p>After completion of study therapy, patients are followed up every 3 months.</p>"
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    }
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  {
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    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "The PFS distributions of the two treatment arms will be estimated by Kaplan-Meier.\nPFS distributions will be compared by an unstratified log-rank test."
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    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Percentage of progression-free"
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    "value": "Up to 24 weeks"
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    "value": "Ninety-five percent confidence intervals will be calculated for the percent progression-free at 24 weeks in each arm via binomial proportions"
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    "value": "From first treatment day until death, assessed up to 4 years"
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    "value": "Using Kaplan-Meier method."
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  {
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    "value": {
      "measure": "Toxicity as assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0",
      "timeFrame": "Up to 4 years"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>ELIGIBILITY CRITERIA FOR ARM A AND ARM B</li><li>Patients must have histologically or cytologically confirmed ER+ positive breast cancer</li><li>Patients must be postmenopausal, defined as: (1) a history of at least 12 months without spontaneous menstrual bleeding, (2) prior bilateral salpingo-oophorectomy, with or without hysterectomy, (3) age &gt;= 55 years with a prior hysterectomy with or without oophorectomy, (4) age &lt; 55 years with a prior hysterectomy without oophorectomy or unknown status, with a documented FSH level in postmenopausal range within 4 week s of registration, (5) receiving a gonadotropin releasing hormone analog (GnRH) to suppress ovarian function (eg, goserelin 3.6 mg q 4 weeks)</li><li>Patients must have stage IV disease or inoperable locally advanced disease</li><li>Patients may have measurable disease only, non-measurable disease only, or both (RECIST 1.1); it is anticipated that at least 50% of patients will have only non-measurable disease</li><li>Patients are required to have disease that is resistant to aromatase inhibitor (AI), which is defined either as relapse while receiving adjuvant A.I. therapy (ie, anastrazole, letrozole, or exemestane), and&#x2F;or disease progression after one or more A.I.s for metastatic disease; prior exposure to more than one AI is permitted</li><li>Patient may have had prior tamoxifen but are not required to</li><li>Patients may have received up to one prior chemotherapy regimen for metastatic disease</li><li>Patients may have received prior bevacizumab</li><li>Patients who have received up to 2 doses of fulvestrant given within a 4 week period prior to registration are eligible; the interval between the first fulvestrant dose and registration must be 6 weeks or less; patients may have received EITHER 250 mg or 500 mg of fulvestrant previously; if the patient has received 250 mg, they will receive the 500 mg loading dose on study day -14; if they already received 500 mg, they will begin the study on day +1</li><li>Life expectancy of greater than 3 months</li><li>ECOG performance status =&lt; 2 (Karnofsky &gt;= 60%)</li><li>Leukocytes &gt;= 3,000&#x2F;mcL</li><li>Absolute neutrophil count &gt;= 1,500&#x2F;mcL</li><li>Platelets &gt;= 100,000&#x2F;mcL</li><li>Total bilirubin within normal institutional limits</li><li>AST(SGOT)&#x2F;ALT(SGPT) =&lt; 2.5 x institutional upper limit of normal</li><li>Creatinine within normal institutional limits OR</li><li>Creatinine clearance &gt;= 60 mL&#x2F;min&#x2F;1.73\nm^2 for patients with creatinine levels above institutional normal</li><li>Patients must be disease-free of prior invasive malignancies for &gt;= 5 years with the exception of: curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix</li><li>Patients must have the ability to understand and the willingness to sign a written informed consent document</li><li>The effects of bortezomib on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately</li><li>ELIGIBILITY CRITERIA FOR ARM C</li><li>Previously met all eligibility criteria for arms A and B and registered on trial to arm A (fulvestrant alone)</li><li>Disease progression on arm A and agreeable to crossover to arm C</li><li>Has received no intervening therapy (ie, alternative endocrine therapy, chemotherapy, biologic therapy) between disease progression on arm A and registration an arm C</li><li>ECOG performance status 0-2</li><li>Tumor measurements (eg, CT scan of chest&#x2F;abdomen&#x2F;pelvis) within 4 weeks of registration to arm C</li><li><p>Normal organ and marrow function as defined below (within 2 weeks of registration on arm C):</p><ul><li>Leukocytes &gt;= 3,000&#x2F;mcL</li><li>Absolute neutrophil count &gt;= 1,500&#x2F;mcL</li><li>Platelets &gt;= 100,000&#x2F;mcL</li><li>Total bilirubin within normal institutional limits</li><li>AST(SGOT)&#x2F;ALT(SGPT) =&lt; 2.5 x institutional upper limit of normal</li><li>Creatinine within normal institutional limits OR</li><li>Creatinine clearance &gt;= 60 mL&#x2F;min&#x2F;1.73\nm^2 for patients with creatinine levels above institutional normal</li></ul></li></ul><p>Exclusion Criteria:</p><ul><li>EXCLUSION CRITERIA FOR ARM A AND ARM B</li><li>Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier</li><li>Patients may not be receiving any other investigational agents</li><li>Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events</li><li>Presence of rapidly progressive, life-threatening metastases; this includes patients with extensive hepatic involvement (&gt; 50% of the liver involved), symptomatic lymphangitic metastases, or brain or leptomeningeal involvement</li><li>History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or fulvestrant</li><li>Patients who are concomitantly receiving bortezomib and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy</li><li>Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements</li><li>HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with bortezomib; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated</li><li>Patients who have previously received fulvestrant</li><li>Patients who have previously received bortezomib</li><li>Concomitant anticancer treatment with the following exceptions: (1) bisphosphonates for bone metastases, (2) a GnRH analog is permitted if the patient had progressive disease on a GnRH analog plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be discontinued</li><li>Grade 2 or more peripheral neuropathy because the dose limiting toxicity of bortezomib is neuropathy</li></ul>"
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