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SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases

StatusRecruiting
PhasePhase 1/2
Started2021-11-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Nov 5, 2026 → Jul 2027
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-08
Study Identification, Study Status v17
Primary completion pushed: 2026-11-05 → 2027-07
Completion pushed: 2026-12 → 2027-12
Study title-3 characters
Stereotactic RadiationSR & Abemaciclib With/wo Imlunestrant in the Management of HR+/HER2- Breast CancerCA Brain Metastases
2026-02-04
Study Status, Contacts/Locations v16
Primary completion date2026-03→2026-11-05
Completion date2026-03→2026-12
Study sitesdetails revised at 1 of 2 sites
2025-11-11
Study Status, Contacts/Locations v15
Study sitescontacts updated at 1 of 2 sites
2025-08-14
Study Status, Contacts/Locations v14
Study sites1→2
2025-04-10
Study Status v13
Primary completion date2025-03→2026-03
Show 12 earlier versions
2025-01-28
Study Status v12
Primary completion date2024-12-31→2025-03
Completion date2024-12-31→2026-03
2024-11-27
3 amendments v9-v11
3 re-verifications since 2024-01-24, no change to tracked fields
2023-08-16
Study Status v8
Primary completion date2023-12-31→2024-12-31
2023-03-27
Study Status, Eligibility v7
Eligibility criteria+194 characters
[...] dia and ventricular fibrillation), or sudden cardiac arrest PatientsHistory withof prior historymalignancy of nonbreast cancer malignancies should have no evidence of disease ≥within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of >90%), such as but not limited to, non-melanoma skin carcinoma, or stage I endometriod uterine cancer, and others at the discretion of the PI. Major surgery or significant traumatic injury that has not [...]
2022-11-01
Study Status v6
Start date2021-07-28→2021-11-30
2022-05-17
Study Status v5
Re-verified, no change to tracked fields
2022-03-03
Study Status, Eligibility v4
Eligibility criteriarevised
[...] st cancer malignancies should have no evidence of disease ≥ 52 years Major surgery or significant traumatic injury that ha [...]
2021-12-22
Study Status v3
Re-verified, no change to tracked fields
2021-10-26
Study Status, Eligibility, IPDSharing v2
Eligibility criteria+64 characters
[...] whole brain radiation therapy Prior receipt of abemaciclib in the setting of brain metastases or in the past 6 months for the treatment of metastatic disease. All toxicities attributed to prior anticancer therapy must [...]
2021-07-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-08-01→confirmed 2021-07-28
Study sitesdetails revised at 1 of 1 site
2021-06-09
Original filing
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
Trial Details
NCT Number NCT04923542
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Eli Lilly and Company
Conditions Brain Metastases, HR+ Metastatic Breast Cancer
Enrollment 31 participants
Start Date 2021-11-30
Primary Completion 2027-07 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-28