NCT00629616
Version 7 to 8 · UNICANCER
Patch inspector
Manual review pending.
arms_or_interventions_changedesign_info_changeenrollment_type_changeprimary_outcome_any_changesecondary_outcome_any_change [
{
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"signal": "timeline_shift",
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"new_type": "ESTIMATED",
"old_type": null,
"severity": "medium",
"direction": "unknown",
"new_value": "2014-09",
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] 2149af1aecf3993652ae4353d43f1557bd4595f711fc0018f130c569e0a59cb5/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Clinical tumor response at 6 months as assessed by RECIST criteria
Clinical tumor response as assessed by RECIST criteria
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. 6 months
/protocolSection/designModule/designInfo/interventionModel design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. PARALLEL
/protocolSection/designModule/enrollmentInfo/type enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority. ESTIMATED
ACTUAL
/protocolSection/armsInterventionsModule/interventions/0/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. 1 mg/day for either 4 months or 6 months depending on the clinical evaluation
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Arm A" ]
/protocolSection/armsInterventionsModule/interventions/1/description arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. 500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation
/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [ "Arm B" ]
/protocolSection/armsInterventionsModule/interventions/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "adjuvant therapy",
"type": "PROCEDURE"
} /protocolSection/armsInterventionsModule/interventions/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "neoadjuvant therapy",
"type": "PROCEDURE"
} /protocolSection/armsInterventionsModule/interventions/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "therapeutic conventional surgery",
"type": "PROCEDURE"
} /protocolSection/armsInterventionsModule/interventions/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "radiation therapy",
"type": "RADIATION"
} /protocolSection/armsInterventionsModule/armGroups arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. [
{
"type": "EXPERIMENTAL",
"label": "Arm A",
"description": "Anastrozole",
"interventionNames": [
"Drug: anastrozole"
]
},
{
"type": "EXPERIMENTAL",
"label": "Arm B",
"description": "Fulvestrant",
"interventionNames": [
"Drug: fulvestrant"
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] /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Post surgery
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Post surgery
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI at baseline, after the first month of treatment, and then before surgery
Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. at baseline, after the first month of treatment, and then before surgery
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 3 years
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Relapse-free survival rate at 3 years
Relapse-free survival rate
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 3 years
/protocolSection/outcomesModule/secondaryOutcomes/5/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Event-free survival rate at 3 years
Event-free survival rate
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 3 years
/protocolSection/outcomesModule/secondaryOutcomes/6/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival rate at 3 years
Overall survival rate
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. 3 years
/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. During neoadjuvant treatment
/protocolSection/statusModule/completionDateStruct completion_timeline_change Completion date changes are operational timeline signals. {
"date": "2014-09",
"type": "ESTIMATED"
} /protocolSection/contactsLocationsModule/overallOfficials/0/name Michelle Tubiana-Hulin, MD
Florence Lerebours, MD
/protocolSection/contactsLocationsModule/overallOfficials/0/role PRINCIPAL_INVESTIGATOR
/protocolSection/contactsLocationsModule/locations/0/status RECRUITING
/protocolSection/contactsLocationsModule/locations/0/contacts [
{
"name": "Contact Person",
"role": "CONTACT",
"phone": "33-4-7327-8137"
}
] /protocolSection/contactsLocationsModule/locations/1/status RECRUITING
/protocolSection/contactsLocationsModule/locations/1/contacts [
{
"name": "Contact Person",
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"phone": "33-5-5505-6100"
}
] /protocolSection/contactsLocationsModule/locations/2/status RECRUITING
/protocolSection/contactsLocationsModule/locations/2/contacts [
{
"name": "Contact Person",
"role": "CONTACT",
"phone": "33-1-44-32-4645"
}
] /protocolSection/contactsLocationsModule/locations/3/status RECRUITING
/protocolSection/contactsLocationsModule/locations/3/contacts [
{
"name": "Contact Person",
"role": "CONTACT",
"phone": "33-2-9925-3280"
}
] /protocolSection/contactsLocationsModule/locations/4/status RECRUITING
/protocolSection/contactsLocationsModule/locations/4/contacts [
{
"name": "Contact Person",
"role": "CONTACT",
"email": "f.lerebours@stcloud-huguenin.org",
"phone": "33-147-11-1515"
}
] /protocolSection/contactsLocationsModule/locations/5/status RECRUITING
/protocolSection/contactsLocationsModule/locations/5/contacts [
{
"name": "Contact Person",
"role": "CONTACT",
"phone": "33-1-4211-4995"
}
] /protocolSection/statusModule/statusVerifiedDate 2009-07
2012-07
/protocolSection/statusModule/lastUpdateSubmitDate 2010-03-19
2012-07-20
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2010-03-22
2012-07-23
/protocolSection/identificationModule/orgStudyIdInfo/id CDR0000585501
CARMINA02
/protocolSection/identificationModule/secondaryIdInfos/0/id FNCLCC-CARMINA-02/0609
CARMINA-02/0609
/protocolSection/identificationModule/secondaryIdInfos/0/type OTHER
/protocolSection/identificationModule/secondaryIdInfos/0/domain UNICANCER
/protocolSection/identificationModule/secondaryIdInfos/1/id EU-20805
2006-006409-10
/protocolSection/identificationModule/secondaryIdInfos/1/type EUDRACT_NUMBER
/protocolSection/identificationModule/secondaryIdInfos/2/id FNCLCC-NIMFEA
NIMFEA
/protocolSection/identificationModule/secondaryIdInfos/2/type OTHER
/protocolSection/identificationModule/secondaryIdInfos/2/domain UNICANCER
/protocolSection/identificationModule/secondaryIdInfos/3 {
"id": "ZENECA-FNCLCC-CARMINA-02-0609"
} /protocolSection/identificationModule/organization/fullName National Cancer Institute (NCI)
UNICANCER
/protocolSection/identificationModule/organization/class NIH
OTHER
/protocolSection/identificationModule/briefTitle Anastrozole or Fulvestrant in Treating Postmenopausal Women With Stage II or Stage III Breast Cancer That Can Be Removed By Surgery
Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer
/protocolSection/identificationModule/acronym NIMFEA
/protocolSection/sponsorCollaboratorsModule/responsibleParty {
"type": "SPONSOR"
} /protocolSection/oversightModule {
"oversightHasDmc": true
} /protocolSection/statusModule/overallStatus RECRUITING
ACTIVE_NOT_RECRUITING
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