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NCT05467891 · ClinicalTrials.gov registry record · Phase 2
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
A Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Oana Danciu.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05467891: Recruiting Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Oana Danciu.
NCT05467891 is a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer that is actively recruiting participants, run by Oana Danciu. The registered enrollment target is 200 participants, below the 251-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05467891, a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Cancer, is actively recruiting participants, sponsored by Oana Danciu.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
Primary Outcome
Estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant). RFS is defined as interval from registration until invasive or DCIS recurrence in the ipsilateral breast or locoregionally, invasive recurrence at a distant site, or death from breast cancer or any other cause, whichever occurs first. The censoring time is the completion of study at 6 years (3 years of patient accrual and 3 years of follow up time). The RFS at 3 years will
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Ribociclib
Study Locations (20)
Michigan
- University of Michigan Health System - Ann Arbor
- University of Michigan Health-West - Wyoming
Virginia
- University of Virginia Health System - Charlottesville
- Virginia Commonwealth University - Richmond
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- University of Arizona - Phoenix
Florida
- Orlando Health Cancer Institute - Orlando
Illinois
- University of Illinois Cancer Center - Chicago
Indiana
- Parkview Research Center - Fort Wayne
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2029-08 |
| Phase | Phase 2 |
What NCT05467891 shows while recruiting
NCT05467891 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 251-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (20% lower).
The record links to 3 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT05467891 names 20 study sites across 18 states, led by Michigan, Virginia, Alabama.
Frequently Asked Questions
What is clinical trial NCT05467891 about?
NCT05467891 is a clinical study titled "Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer". This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
What is the current status of trial NCT05467891?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2022-09-13. Estimated completion is 2029-08.
What conditions does trial NCT05467891 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer, Locoregional Recurrence.
What interventions are being tested in trial NCT05467891?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT05467891?
This trial is sponsored by Oana Danciu, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05467891 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05467891's enrollment target sits among peer trials
200 11th of 49 higher than 39 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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