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Trilaciclib plus chemotherapy vs chemotherapy alone in patients with metastatic triple-negative breast cancer: A multicentre, randomised, open-label, phase 2 trial

The Lancet Oncology Oct 04, 2019

Tan AR, Wright GS, Thummala AR, et al. - Researchers evaluated whether trilaciclib (an intravenous cell-cycle inhibitor) plus gemcitabine and carboplatin chemotherapy has activity and safety in patients with metastatic triple-negative breast cancer. The participants were recruited from 26 sites in the USA, 3 in Serbia, 2 in North Macedonia, 1 in Croatia, and 1 in Bulgaria. They randomly allocated eligible patients (1:1:1) to treatment with intravenous gemcitabine 1000 mg/m2 and intravenous carboplatin on days 1 and 8 (group 1), gemcitabine and carboplatin plus intravenous trilaciclib 240 mg/m2 on days 1 and 8 (group 2), or gemcitabine and carboplatin on days 2 and 9 plus trilaciclib on days 1, 2, 8, and 9 (group 3) of 21-day cycles. They assessed the duration of severe neutropenia during cycle 1 and the appearance of severe neutropenia during the treatment duration (primary endpoints), as well as overall survival (secondary endpoint). Among participants, no significant differences were found in myelosuppression endpoints with trilaciclib plus gemcitabine and carboplatin. However, the general good tolerability of the regimen, as well as encouraging overall survival outcomes were evident.
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