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Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

StatusRecruiting
PhasePhase 2
Started2020-03-25
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Aug 21, 2026 → May 21, 2027
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-10-02
Primary completion pushed: 2026-08-21 → 2027-05-21
Completion pushed: 2026-08-21 → 2027-05-21
2026-04-30
Study Status, Contacts/Locations v15
Study sites3→6
2025-09-19
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v14
Primary completion date2025-08-21→2026-08-21
Completion date2025-08-21→2026-08-21
Study sitescontacts updated at 2 of 3 sites
Study titlerevised
Abemaciclib and Endocrine Therapy in Older Patients withWith Breast Cancer.
2024-09-17
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v13
Primary completion date2024-08-21→2025-08-21
Completion date2024-08-21→2025-08-21
Study sitescontacts updated at 2 of 3 sites
Study titlerevised
Abemaciclib and Endocrine Therapy in Older Patients Withwith Breast Cancer.
2024-01-18
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v12
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2023-12-15→2024-08-21
Completion date2023-12-15→2024-08-21
Enrollment target25→43
Study sitesdetails revised at 3 of 3 sites
Show 11 earlier versions
2023-09-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 40→confirmed 25
Study sitesdetails revised at 3 of 3 sites
2023-08-10
Study Status, Contacts/Locations v10
Study sites1→3
2022-11-01
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2022-03-07
Study Status v8
Primary completion date2022-02-21→2023-12-15
Completion date2022-02-21→2023-12-15
2022-02-28
Study Status v7
Primary completion date2022-02-03→2022-02-21
Completion date2022-02-03→2022-02-21
Start date2020-02-21→2020-03-25
2021-10-04
Study Identification, Study Status v6
Study title-35 characters
Abemaciclib Monotherapyand Endocrine Therapy in Treating Older Patients With Hormone Receptor Positive Metastatic Breast Cancer.
2021-09-24
Suspended→Recruiting Study Identification, Study Status, Contacts/Locations v5
Trial statusSuspended→Recruiting
Reason stoppedpending amend→not stated
Study sitesdetails revised at 1 of 1 site
2021-07-04
Recruiting→Suspended Study Status, Contacts/Locations v4
Trial statusRecruiting→Suspended
Reason stoppednot stated→pending amend
Study sitesdetails revised at 1 of 1 site
2020-05-21
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Eligibility criteria-72 characters
[...] s Life expectancy > 6 months Ability to read and understand oneEnglish or more of the following languages for questionnaires: English, Spanish, Chinese, Japanese, Korean, or French Measurable or non-measurable disease Histologically or cyto [...] syndrome, total bilirubin =< 2.0 x ULN or direct bilirubin within normal limits (WLN) Creatinine clearance of >= 30 mL/min per 24 hour urine test [...]
Secondary endpoints16 entries, revised
Overall Treatmenttreatment Utilityutility (OTU) response
Study sitescontacts updated at 1 of 1 site
2020-04-29
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2020-03-26
Study Status, Outcome Measures v1
Start dateestimated 2020-03-21→confirmed 2020-02-21
Secondary endpoints16 entries, revised
Dose changesreductions
2020-03-10
Original filing
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
Trial Details
NCT Number NCT04305834
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Enrollment 43 participants
Start Date 2020-03-25
Primary Completion 2027-05-21 (estimated)
Study Completion 2027-05-21 (estimated)
Updated on ClinicalTrials.gov 2026-10-01