Back to feed

NCT01142401

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

A Randomized Phase II Study of Fulvestrant vs. Fulvestrant in Combination With Bortezomib in Women With ER Positive Metastatic Breast Cancer

ClinicalTrials.gov
Sponsor
National Cancer Institute (NCI)
Status
Completed
Versions
54
Adjacent patches
53
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

11 shown
Triage: High
2010-08-03
Eligibility Change
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/descriptionModule/detailedDescription
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Critical
2011-03-07
Primary Outcome Change
v2 to v3 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations
/protocolSection/designModule/designInfo/interventionModel
Triage: Critical
2013-05-15
Primary Outcome Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/armGroups/0/type
Triage: Critical
2014-02-10
Primary Outcome Change
v6 to v7 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
2014-07-18
Enrollment Change
v11 to v12 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/11
/protocolSection/contactsLocationsModule/locations/15
/protocolSection/contactsLocationsModule/locations/18
Triage: High
2014-11-21
Arm Intervention Change
v18 to v19 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
2015-04-24
Arm Intervention Change
v31 to v32 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: Low
2017-05-23
Timeline Minor Adjustment
v49 to v50 Late Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Critical
2017-10-04
Primary Outcome Change
v50 to v51 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/armsInterventionsModule/armGroups/2/description
/protocolSection/conditionsModule/conditions/1
Triage: Low
2020-08-14
Timeline Actual Date Correction
v51 to v52 Late Recruitment Inspect patch
/annotationSection
/protocolSection/conditionsModule/conditions/0
/protocolSection/conditionsModule/conditions/1
Triage: Medium
2023-11-03
Timeline Shift
v52 to v53 Late Recruitment Inspect patch Evidence Record
/annotationSection
/hasResults
/protocolSection/outcomesModule/primaryOutcomes/0/description