Trial Identifiers
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Scientific Title
A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
Commercial Sponsor
G1 Therapeutics, Inc
Summary
This study will have two separate cohorts, that will both follow the same general study design with identical treatment arms. Cohort 1 will evaluate participants 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 naive. Cohort 2 will evaluate PD-L1 positive participants receiving second-line therapy following prior PD-L1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting. Within each cohort, participants will be randomly assigned to either the Experimental arm or Placebo Comparator arm. In the Experimental Arm, participants will receive Trilaciclib (240mg/m2 administered intravenously [via IV] over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in combination with gemcitabine (1000mg/m2, administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (AUC 2, administered via IV on Day 1 and Day 8 of each 21-day cycle). In the Placebo Comparator Arm, participants will receive placebo (administered via IV over 30 mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle), in addition to gemcitabine (administered via IV on Day 1 and Day 8 of each 21-day cycle) and carboplatin (administered via IV on Day 1 and Day 8 of each 21-day cycle).