Journal article

Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first-or second-line treatment of patients with metastatic triple-negative breast cancer

Rebecca A Dent, Geoffrey J Lindeman, Mark Clemons, Hans Wildiers, Arlene Chan, Nicole J McCarthy, Christian F Singer, Elizabeth S Lowe, Claire L Watkins, James Carmichael



INTRODUCTION: This Phase I study evaluated the safety, tolerability and efficacy of olaparib, a potent oral poly(ADPribose) polymerase (PARP) inhibitor, in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC). METHODS: Eligible patients who had received ≤1 prior cytotoxic regimen for mTNBC were treated with olaparib 200 mg bid continuously plus weekly paclitaxel 90 mg/m2 for three weeks per four-week cycle. Dose modifications in a large proportion of patients due to neutropenia resulted in enrollment of a second cohort of patients who, if they experienced grade ≥2 neutropenia in cycle 1, received granulocyte-colony stimulating factor, which was contin..

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Funding Acknowledgements

We thank Dr Juliet Fawcett, from Mudskipper Bioscience, who provided editorial assistance funded by AstraZeneca. This study has previously been presented in abstract and poster format at the American Society of Clinical Oncology (ASCO) 2010 Congress in Chicago, IL. This study was supported by AstraZeneca.