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Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Study acronym: Free-HER
StatusActive, Not Recruiting
PhaseNot applicable
Started2023-07-17
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
See other at-risk trials from University of Miami

Amendment history

2026-09-25
critical
Enrollment closed, study ongoing
Primary completion pushed: 2026-07-31 → 2027-07-31
Completion pushed: 2029-07-31 → 2030-07-31
2025-08-11
minor
Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2024-09-03
minor
Study Status, Oversight, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2023-09-22
minor
Study Status v1
Primary completion date2026-10-31→2026-07-31
Completion date2029-10-31→2029-07-31
Start dateestimated 2023-10-01→confirmed 2023-07-17
2023-07-17
minor
Original filing
The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.
Trial Details
NCT Number NCT05959291
Lead Sponsor University of Miami
Conditions HER2-positive Metastatic Breast Cancer, Stage IV Breast Cancer
Enrollment 20 participants
Start Date 2023-07-17
Primary Completion 2027-07-31 (estimated)
Study Completion 2030-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-24