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NCT05113966 · ClinicalTrials.gov registry record · Phase 2
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
A Phase 2 study, sponsored by G1 Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT05113966: Clinical Trial Phase 2 study, sponsored by G1 Therapeutics.
NCT05113966 is a Phase 2 study that was terminated before completion, run by G1 Therapeutics. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05113966, a Phase 2 study, was terminated before completion, sponsored by G1 Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatments, at least 1 in the metastatic setting.
Primary Outcome
Progression free survival was defined as the time (months) from the date of the first dose of the study drug to the date of documented radiographic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG Trilaciclib
- DRUG Sacituzumab Govitecan-hziy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2024-06-13 |
| Phase | Phase 2 |
Why NCT05113966 stopped before completion
NCT05113966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Trilaciclib is the first listed.
NCT05113966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05113966 about?
NCT05113966 is a clinical study titled "Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer". This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) who received at least 2 prior treatm...
What is the current status of trial NCT05113966?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-12-08. Estimated completion is 2024-06-13.
What interventions are being tested in trial NCT05113966?
The interventions under investigation include: Trilaciclib (DRUG), Sacituzumab Govitecan-hziy (DRUG).
Who is sponsoring clinical trial NCT05113966?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05113966's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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