A phase II study of talazoparib after platinum or cytotoxic nonplatinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO)
dc.contributor.author | Turner, N | |
dc.contributor.author | Telli, M | |
dc.contributor.author | Rugo, H | |
dc.contributor.author | Mailliez, A | |
dc.contributor.author | Ettl, J | |
dc.contributor.author | Grischke, E | |
dc.contributor.author | Mina, L | |
dc.contributor.author | Balmana, J | |
dc.contributor.author | Fasching, P | |
dc.contributor.author | Hurvitz, S | |
dc.contributor.author | Wardley, Andrew M | |
dc.contributor.author | Chappey, C | |
dc.contributor.author | Hannah, A | |
dc.contributor.author | Robson, M | |
dc.date.accessioned | 2019-02-08T15:20:09Z | |
dc.date.available | 2019-02-08T15:20:09Z | |
dc.date.issued | 2018 | en |
dc.identifier.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. | en |
dc.identifier.pmid | 30563931 | en |
dc.identifier.doi | 10.1158/1078-0432.CCR-18-1891 | en |
dc.identifier.uri | http://hdl.handle.net/10541/621531 | |
dc.description.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. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1158/1078-0432.CCR-18-1891 | en |
dc.title | A phase II study of talazoparib after platinum or cytotoxic nonplatinum regimens in patients with advanced breast cancer and germline BRCA1/2 mutations (ABRAZO) | en |
dc.type | Article | en |
dc.contributor.department | Breast Cancer Now Research Centre, Institute of Cancer Research and The Royal Marsden Hospital | en |
dc.identifier.journal | Clincal Cancer Research | en |
dc.description.note | en] |