Phase I/Ib study of olaparib and carboplatin in women with triple negative breast cancer.

Lee JM, Hays JL, Chiou VL, Annunziata CM, Swisher EM, Harrell MI, Yu M, Gordon N, Sissung TM, Ji J, Figg WD, Minasian L, Lipkowitz S, Wood BJ, Doroshow J, Kohn EC
Oncotarget 8 79175-79187 10/03/2017

Abstract

PURPOSE: To investigate the safety, activity, and potential biomarkers of response to olaparib and carboplatin combination in sporadic triple negative breast cancer (TNBC). EXPERIMENTAL DESIGN: Metastatic or recurrent TNBC patients with no germline

RESULTS: 28 women were treated (median 5 prior regimens [0-12]). Dose-limiting toxicity was thrombocytopenia, and symptomatic hyponatremia with carboplatin AUC5. The maximum tolerated dose was olaparib 400mg bid+carboplatin AUC4. Grade 3 and 4 adverse events included neutropenia (36%), thrombocytopenia (11%), and anemia (11%). Responses included 1 complete response (CR; 69

CONCLUSIONS: The olaparib/carboplatin combination is tolerable and has modest activity in sporadic TNBC patients. Further evaluation of predictive biomarkers to identify those with

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