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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 is a Phase 2 study that has completed, run by G1 Therapeutics. The registered enrollment target is 24 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05112536
The ClinicalTrials.gov registry entry for NCT05112536 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is G1 Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT05112536 reports 0 study locations.
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.
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