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NCT05305924 · ClinicalTrials.gov registry record · Phase 2
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
A Phase 2 study of HER2-Negative Breast Cancer and ER Positive Breast Cancer, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05305924: Recruiting Phase 2 study of HER2-Negative Breast Cancer and ER Positive Breast Cancer, sponsored by The Methodist Hospital Research Institute.
NCT05305924 is a Phase 2 study of HER2-Negative Breast Cancer and ER Positive Breast Cancer that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 28 participants, below the 255-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05305924, a Phase 2 study of HER2-Negative Breast Cancer and ER Positive Breast Cancer, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
Primary Outcome
Time to treatment failure (TTF) for fulvestrant plus abemaciclib with a 1-month run-in of fulvestrant in patients with ER-positive, HER2-negative metastatic breast cancer that has progressed on a CDK4/6 inhibitor in combination with an AI, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Conditions Studied
Interventions
- DRUG Fulvestrant Run-In
Study Locations (1)
Texas
- Houston Methodist Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 2 |
What NCT05305924 shows while recruiting
NCT05305924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 255-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Fulvestrant Run-In is the first listed.
NCT05305924 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05305924 about?
NCT05305924 is a clinical study titled "Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer". The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage such patients.
What is the current status of trial NCT05305924?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2021-02-25. Estimated completion is 2027-12-01.
What conditions does trial NCT05305924 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, ER Positive Breast Cancer.
What interventions are being tested in trial NCT05305924?
The interventions under investigation include: Fulvestrant Run-In (DRUG).
Who is sponsoring clinical trial NCT05305924?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05305924 being conducted?
This trial has 1 study location across Texas. 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 NCT05305924's enrollment target sits among peer trials
28 37th of 49 higher than 12 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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