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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)
G1 Therapeutics, Inc.
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).