A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: Design and rationale Journal Article


Authors: Isakoff, S. J.; Puhalla, S.; Domchek, S. M.; Friedlander, M.; Kaufman, B.; Robson, M.; Telli, M. L.; Diéras, V.; Han, H. S.; Garber, J. E.; Johnson, E. F.; Maag, D.; Qin, Q.; Giranda, V. L.; Shepherd, S. P.
Article Title: A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: Design and rationale
Abstract: Veliparib is an orally administered poly(ADP-ribose) polymerase inhibitor that is being studied in Phase I-III clinical trials, including Phase III studies in non-small-cell lung cancer, ovarian cancer and breast cancer. Tumor cells with deleterious BRCA1 or BRCA2 mutations are deficient in homologous recombination DNA repair and are intrinsically sensitive to platinum therapy and poly(ADP-ribose) polymerase inhibitors. We describe herein the design and rationale of a Phase II trial investigating whether the addition of veliparib to temozolomide or carboplatin/paclitaxel provides clinical benefit over carboplatin/paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer harboring a deleterious BRCA1 or BRCA2 germline mutation (Trial registration: EudraCT 2011-002913-12, NCT01506609). © 2015 AbbVie Inc.
Keywords: dna damage; breast cancer; brca1; brca2; synthetic lethality; parp inhibitor; veliparib; parp; parp trapping
Journal Title: Future Oncology
Volume: 13
Issue: 4
ISSN: 1479-6694
Publisher: Future Medicine  
Date Published: 2017-02-01
Start Page: 307
End Page: 320
Language: English
DOI: 10.2217/fon-2016-0412
PROVIDER: scopus
PUBMED: 27739325
PMCID: PMC5618936
DOI/URL:
Notes: Article -- Export Date: 2 February 2017 -- Source: Scopus
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  1. Mark E Robson
    677 Robson