A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO)

A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO)

To assess talazoparib activity in germline mutation carriers with advanced breast cancer. ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline mutation carriers with a response to prior platinum with no progression on or within 8 weeks of the last pl...

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Veröffentlicht in:Clinical cancer research 2019-05, Vol.25 (9), p.2717-2724
Hauptverfasser: Turner, Nicholas C, Telli, Melinda L, Rugo, Hope S, Mailliez, Audrey, Ettl, Johannes, Grischke, Eva-Maria, Mina, Lida A, Balmaña, Judith, Fasching, Peter A, Hurvitz, Sara A, Wardley, Andrew M, Chappey, Colombe, Hannah, Alison L, Robson, Mark E
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container_end_page 2724
container_issue 9
container_start_page 2717
container_title Clinical cancer research
container_volume 25
creator Turner, Nicholas C
Telli, Melinda L
Rugo, Hope S
Mailliez, Audrey
Ettl, Johannes
Grischke, Eva-Maria
Mina, Lida A
Balmaña, Judith
Fasching, Peter A
Hurvitz, Sara A
Wardley, Andrew M
Chappey, Colombe
Hannah, Alison L
Robson, Mark E
description To assess talazoparib activity in germline mutation carriers with advanced breast cancer. ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline 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 advanced breast cancer. Primary endpoint was confirmed objective response rate (ORR) by independent radiological assessment. We enrolled 84 patients (cohort 1, = 49; cohort 2, = 35) from May 2014 to February 2016. Median age was 50 (range, 31-75) years. Triple-negative breast cancer (TNBC) incidence was 59% (cohort 1) and 17% (cohort 2). Median number of prior cytotoxic regimens for advanced breast cancer was two and four, respectively. Confirmed ORR was 21% [95% confidence interval (CI), 10-35; cohort 1] and 37% [95% CI, 22-55; cohort 2]. Median duration of response was 5.8 and 3.8 months, respectively. Confirmed ORR was 23% ( ), 33% ( ), 26% (TNBC), and 29% (hormone receptor-positive). The most common all-grade adverse events (AE) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in 3 (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval 6 months). Talazoparib exhibited promising antitumor activity in patients with advanced breast cancer and germline mutation.
doi_str_mv 10.1158/1078-0432.CCR-18-1891
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ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline 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 advanced breast cancer. Primary endpoint was confirmed objective response rate (ORR) by independent radiological assessment. We enrolled 84 patients (cohort 1, = 49; cohort 2, = 35) from May 2014 to February 2016. Median age was 50 (range, 31-75) years. Triple-negative breast cancer (TNBC) incidence was 59% (cohort 1) and 17% (cohort 2). Median number of prior cytotoxic regimens for advanced breast cancer was two and four, respectively. Confirmed ORR was 21% [95% confidence interval (CI), 10-35; cohort 1] and 37% [95% CI, 22-55; cohort 2]. Median duration of response was 5.8 and 3.8 months, respectively. Confirmed ORR was 23% ( ), 33% ( ), 26% (TNBC), and 29% (hormone receptor-positive). The most common all-grade adverse events (AE) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in 3 (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval &lt;8 weeks; 47% ORR with interval &gt;6 months). 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The most common all-grade adverse events (AE) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in 3 (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval &lt;8 weeks; 47% ORR with interval &gt;6 months). 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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)
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