NCT00490139
Version 102 to 103 · Novartis Pharmaceuticals
Patch inspector
Manual review pending.
arms_or_interventions_changeenrollment_count_changeprimary_outcome_any_changesecondary_outcome_any_change None recorded.
5e83dc97c435e5147ca1b46fdc7cbbeb417e2c275b7d55a1ed3a5276865d5907/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. End of Study.
/protocolSection/designModule/enrollmentInfo/count enrollment_count_change Enrollment count changes can signal scope or feasibility shifts. 8000
8400
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Drug: Lapatinib
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Drug: Lapatinib
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Drug: Lapatinib
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. Drug: Lapatinib
/protocolSection/armsInterventionsModule/interventions/0 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "Lapatinib",
"type": "DRUG",
"description": "Small molecule inhibitor",
"armGroupLabels": [
"Arm 2: Lapatinib",
"Arm 3: Trastuzumab followed by Lapatinib",
"Arm 4: Lapatinib in combination with Trastuzumab"
]
} /protocolSection/armsInterventionsModule/interventions/2 arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. {
"name": "Lapatinib",
"type": "DRUG",
"description": "Small molecule inhibitor",
"armGroupLabels": [
"Arm 2: Lapatinib",
"Arm 3: Trastuzumab followed by Lapatinib",
"Arm 4: Lapatinib in combination with Trastuzumab"
]
} /protocolSection/outcomesModule/secondaryOutcomes/0/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to recurrence
Overall survival
/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Time to distant recurrence
Time to recurrence
/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/2/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Incidence of brain metastases as first site of breast cancer recurrence
Time to distant recurrence
/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/3/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Safety and Tolerability
Incidence of brain metastases as first site of breast cancer recurrence
/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/4/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Conduct analyses separately for cohorts defined by the presence or absence of cMyc gene amplification
Safety and Tolerability
/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/5/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Conduct analyses separately for cohorts defined by the expression levels of PTEN
Conduct analyses separately for cohorts defined by the presence or absence of cMyc gene amplification
/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/6/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Conduct analyses separately for cohorts defined by the presence or absence of p95HER2 domain
Conduct analyses separately for cohorts defined by the expression levels of PTEN
/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
/protocolSection/outcomesModule/secondaryOutcomes/7/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Overall survival
Conduct analyses separately for cohorts defined by the presence or absence of p95HER2 domain
/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. End of Study
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