EMBRACA
Trial question
What is the role of talazoparib in patients with advanced breast cancer and germline BRCA1/2 mutations?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
98.0% female
2.0% male
N = 431
431 patients (424 female, 7 male).
Inclusion criteria: patients with advanced breast cancer and germline BRCA1/2 mutations.
Key exclusion criteria: active inflammatory breast cancer; CNS metastases; human epidermal receptor 2-positive breast cancer; locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy; cytotoxic chemotherapy within 14 days before randomization; radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization.
Interventions
N=287 talazoparib (at a dose of 1 mg/day).
N=144 standard therapy (capecitabine, eribulin, gemcitabine, or vinorelbine in continuous 21-day cycles).
Primary outcome
Median progression-free survival
8.6 months
5.6 months
8.6 months
6.4 months
4.3 months
2.1 months
0.0 months
Talazoparib
Standard
therapy
Significant
increase ▲
Significant increase in median progression-free survival (8.6 months vs. 5.6 months; HR 1.85, 95% CI 1.41 to 2.44).
Secondary outcomes
No significant difference in median overall survival (22.3 months vs. 19.5 months; HR 1.32, 95% CI 0.94 to 1.81).
Significant increase in objective response rate (62.6% vs. 27.2%; OR 4.99, 99% CI 2.9 to 8.8).
Significant increase in clinical benefit rate at 24 weeks (68.6% vs. 36.1%; OR 4.28, 95% CI 2.69 to 6.83).
Safety outcomes
No significant difference in adverse event.
Conclusion
In patients with advanced breast cancer and germline BRCA1/2 mutations, talazoparib was superior to standard therapy with respect to median progression-free survival.
Reference
Jennifer K Litton, Hope S Rugo, Johannes Ettl et al. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379(8):753-763.
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