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NCT03393845

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042

ClinicalTrials.gov
Sponsor
Nancy Chan, MD
Status
Active Not Recruiting
Versions
18
Adjacent patches
17
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

14 shown
Triage: Low
2018-02-20
Timeline Actualized Earlier
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2018-05-07
Primary Outcome Change
v1 to v2 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/outcomesModule/otherOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Low
2019-02-14
Administrative Contact Change
v3 to v4 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
/protocolSection/contactsLocationsModule/centralContacts/1/phoneExt
Triage: Medium
2020-10-09
Timeline Significant Shift
v4 to v5 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2021-02-03
Arm Intervention Change
v5 to v6 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2021-07-14
Administrative Contact Change
v6 to v7 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
/protocolSection/contactsLocationsModule/locations/0/contacts/0/email
Triage: High
2021-10-26
Eligibility Change
v7 to v8 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
/protocolSection/contactsLocationsModule/centralContacts/1/phoneExt
Triage: High
2021-12-02
Arm Intervention Change
v8 to v9 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/description
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
Triage: High
2022-03-22
Secondary Outcome Change
v9 to v10 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/phone
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
Triage: Critical
2022-09-12
Primary Outcome Change
v11 to v12 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: Medium
2023-01-18
Timeline Significant Shift
v13 to v14 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
/protocolSection/contactsLocationsModule/centralContacts/1/phoneExt
Triage: High
2023-07-03
Enrollment Change
v14 to v15 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2025-12-30
Timeline Major Slip
v15 to v16 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2026-04-06
Timeline Actual Date Correction
v16 to v17 Late Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection
/hasResults