Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) (PRESERVE 2)
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- STATUS
- Recruiting
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- End date
- Oct 25, 2024
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- participants needed
- 250
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- sponsor
- G1 Therapeutics, Inc.
Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.
Description
This study will have two separate cohorts (Cohort 1 and Cohort 2). Both cohorts will follow the same general study conduct/design with similar primary and key secondary endpoints and identical treatment arms.
- Cohort 1 will evaluate patients receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naïve.
- Cohort 2 will evaluate PD-L1 positive patients receiving second-line therapy following prior PD-1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting.
Details
| Condition | TNBC - Triple-Negative Breast Cancer, Breast Cancer |
|---|---|
| Treatment | carboplatin, Placebo, Gemcitabine, Trilaciclib |
| Clinical Study Identifier | NCT04799249 |
| Sponsor | G1 Therapeutics, Inc. |
| Last Modified on | 4 October 2022 |
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