Dataset Information


Phase I study of Veliparib in combination with Cisplatin and Vinorelbine for patients with advanced triple-negative breast cancer (TNBC) and/or BRCA mutation-associated breast cancer

ABSTRACT: PURPOSE: Preclinically, cisplatin is synergistic with vinorelbine and the poly(ADP-ribose) polymerase (PARP) inhibitor veliparib, and has anti-neoplastic activity in TNBC and BRCA mutation-associated breast cancer. This phase I study assessed veliparib with cisplatin and vinorelbine. PATIENTS AND METHODS: A 3+3 dose escalation design evaluated veliparib administered BID for 14 days with cisplatin (75 mg/m2 day 1) and vinorelbine (25 mg/m2 days 1,8) every 21 days, for six to ten cycles, followed by veliparib monotherapy. Pharmacokinetics, measurement of poly(ADP-ribose) in peripheral blood mononuclear cells, and preliminary efficacy were assessed. Immunohistochemistry and gene expression profiling were performed to evaluate potential predictors of response. Thirty-nine samples were assessed, six samples were run as technical duplicates. Two of the samples had a high rate of missing probes and were excluded during the normalization/pre-processing. Each sample represents a pre- or post-treatment breast cancer specimen from individual patients.

ORGANISM(S): Homo Sapiens

SUBMITTER: Vincent Giranda   Jamie Guenthoer  Melissa Griffin  Peggy L Porter  Julie R Gralow  Brenda F Kurland  Vijayakrishna K Gadi  Jennifer M Specht  Sandra Strychor  John A Thompson  Brian F Kiesel  Hannah M Linden  Jan H Beumer  Rosa F Yeh  Elizabeth Swisher  Larissa Korde  Xiaoyu Chai  Eve T Rodler  Stacie Shepherd 

PROVIDER: E-GEOD-72795 | ArrayExpress | 2015-09-09



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