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NCT05112536 · ClinicalTrials.gov registry record · Phase 2
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
A Phase 2 study, sponsored by G1 Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT05112536: Completed Phase 2 study, sponsored by G1 Therapeutics.
NCT05112536 is a Phase 2 study that has completed, run by G1 Therapeutics. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05112536, a Phase 2 study, has completed, sponsored by G1 Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC). This study will have four phases: 1) Screening Phase, 2) Trilaciclib Lead-In Phase, 3) Treatment Phase, and 4) Surgery and Follow-Up Phase. After a screening phase of up to 21 day, each participant will receive trilaciclib single-dose monotherapy during the lead-in phase, followed by a tumor biopsy. During the treatment phase, each participant will receive trilaciclib with standard of care chemotherapy. Immunotherapy may be included during the treatment phase, per standard of care. 3-5 weeks following conclusion of the treatment phase, each participant will undergo definitive surgery. A 30-day Safety Follow-up Visit will occur 30 days after the last dose of trilaciclib and an End of Study Visit will occur within 14 days after definitive surgery.
Primary Outcome
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio. Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in so
Interventions
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Trilaciclib
- DRUG Cylophosphamide
- DRUG Carboplatin (Investigator discretion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2023-03-13 |
| Phase | Phase 2 |
What the finished NCT05112536 record still lists
NCT05112536 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT05112536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05112536 about?
NCT05112536 is a clinical study titled "Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer". The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC). This study will have four phases: 1) Screening Phase, 2)...
What is the current status of trial NCT05112536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-03-03. Estimated completion is 2023-03-13.
What interventions are being tested in trial NCT05112536?
The interventions under investigation include: Doxorubicin (DRUG), Paclitaxel (DRUG), Trilaciclib (DRUG), Cylophosphamide (DRUG), Carboplatin (Investigator discretion) (DRUG).
Who is sponsoring clinical trial NCT05112536?
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 NCT05112536's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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