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Study of Screening Brain MRIs in Stage IV Breast Cancer

StatusRecruiting
PhasePhase 2
Started2021-12-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
Completion pushed: 2026-10 → 2027-06
2026-05-14
Study Status, Study Design, Arms and Interventions, Eligibility v22
Phase changed: not specified → Phase 2
Trial arms changed: 3 → 1
Primary completion pushed: 2026-04-17 → 2026-06-16
2026-02-05
Study Status v21
Re-verified, no change to tracked fields
2025-11-12
Study Status v20
Primary completion date2025-10-07→2026-04-17
2025-08-14
Study Status v19
Re-verified, no change to tracked fields
Show 18 earlier versions
2025-07-31
Study Status v18
Primary completion date2025-06-02→2025-10-07
Completion date2026-06→2026-10
2025-04-10
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusActive, Not Recruiting→Recruiting
Enrollment target118→170
Study sitesdetails revised at 2 of 2 sites
2025-01-30
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-01-05→2025-06-02
Completion date2026-01→2026-06
Enrollment targetestimated 100→confirmed 118
Study sitesdetails revised at 2 of 2 sites
2024-12-17
Study Status v15
Re-verified, no change to tracked fields
2024-09-06
Study Status, Contacts/Locations v14
Study sitescontacts updated at 1 of 2 sites
2024-07-16
Study Status, Contacts/Locations v13
Primary completion date2024-08-31→2025-01-05
Completion date2024-08-31→2026-01
Study sitesdetails revised at 1 of 2 sites
2024-07-05
Study Status v12
Re-verified, no change to tracked fields
2024-01-29
Study Status, Contacts/Locations v11
Study sites1→2
2024-01-25
3 amendments v8-v10
3 re-verifications since 2023-10-17, no change to tracked fields
2023-09-28
Study Status v7
Primary completion date2023-08-31→2024-08-31
Completion date2023-08-31→2024-08-31
2023-07-28
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
2023-02-22
2 amendments v4-v5
2 re-verifications since 2022-09-30, no change to tracked fields
2022-08-19
Study Status, Eligibility v3
Eligibility criteria+101 characters
Inclusion Criteria: Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients Radiographic evidence of stage IV extracranial disease havingin progressedTN pastand firstHER2+ line therapypatients Age ≥ 18 Life expectancy ≥ 6 months Eastern Cooperative Onc [...]
2022-04-15
Study Status v2
Start date2021-10-29→2021-12-21
2021-11-10
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2021-11-09
Original filing
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
Trial Details
NCT Number NCT05115474
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Florida Breast Cancer Foundation
Conditions Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
Enrollment 170 participants
Start Date 2021-12-21
Primary Completion 2026-06-16 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-15