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    A phase II study of talazoparib after platinum or cytotoxic nonplatinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO)

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    Authors
    Turner, N
    Telli, M
    Rugo, H
    Mailliez, A
    Ettl, J
    Grischke, E
    Mina, L
    Balmana, J
    Fasching, P
    Hurvitz, S
    Wardley, Andrew M
    Chappey, C
    Hannah, A
    Robson, M
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    Affiliation
    Breast Cancer Now Research Centre, Institute of Cancer Research and The Royal Marsden Hospital
    Issue Date
    2018
    
    Metadata
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    Abstract
    PURPOSE: To assess talazoparib activity in germline BRCA1/2 mutation carriers with advanced breast cancer (aBC). EXPERIMENTAL DESIGN: ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline BRCA mutation carriers with a response to prior platinum with no progression on or within 8 weeks of the last platinum dose (cohort 1) or ?3 platinum-free cytotoxic regimens (cohort 2) for aBC. Primary endpoint was confirmed objective response rate (ORR) by independent radiological assessment. RESULTS: We enrolled 84 patients (cohort 1, n = 49; cohort 2, n = 35) from May 2014 to February 2016. Median age was 50 (range, 31-75) years. Triple-negative breast cancer incidence was 59% (cohort 1) and 17% (cohort 2). Median number of prior cytotoxic regimens for aBC was two and four, respectively. Confirmed ORR was 21% (95% CI, 10 to 35) (cohort 1) and 37% (95% CI, 22 to 55) (cohort 2). Median duration of response was 5.8 and 3.8 months, respectively. Confirmed ORR was 23% (BRCA1), 33% (BRCA2), 26% (TNBC) and 29% (hormone receptor positive). The most common allgrade adverse events (AEs) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in three (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval <8 weeks; 47% ORR with interval >6 months). CONCLUSIONS: Talazoparib exhibited promising antitumor activity in patients with aBC and germline BRCA mutation.
    Citation
    Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, et al. A phase II study of talazoparib after platinum or cytotoxic nonplatinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO). Clin Cancer Res. 2018 Dec 18.
    Journal
    Clincal Cancer Research
    URI
    http://hdl.handle.net/10541/621531
    DOI
    10.1158/1078-0432.CCR-18-1891
    PubMed ID
    30563931
    Additional Links
    https://dx.doi.org/10.1158/1078-0432.CCR-18-1891
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1158/1078-0432.CCR-18-1891
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