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

Steven J. Isakoff*, Shannon Puhalla, Susan M. Domchek, Michael Friedlander, Bella Kaufman, Mark Robson, Melinda L. Telli, Véronique Diéras, Hyo Sook Han, Judy E. Garber, Eric F. Johnson, David Maag, Qin Qin, Vincent L. Giranda, Stacie P. Shepherd

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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).

Original languageEnglish
Pages (from-to)307-320
Number of pages14
JournalFuture Oncology
Volume13
Issue number4
DOIs
StatePublished - Feb 2017
Externally publishedYes

Funding

FundersFunder number
National Cancer InstituteP30CA008748

    Keywords

    • BRCA1
    • BRCA2
    • DNA damage
    • PARP
    • PARP inhibitor
    • PARP trapping
    • breast cancer
    • synthetic lethality
    • veliparib

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