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Breast cancer with BRCA1 or BRCA2 mutations is sensitive to PARP inhibitors and platinum drugs due to combodyor recombinant repair defects of DNA damage.
in the BROCADE3 trial, the researchers compared the efficacy of veliparib and placebo combined carbotin and yew alcohol treatment for her2-negative advanced breast cancer patients with BRCA1 or BRCA2 embryonic mutations.
BROCADE3 trial, a randomized, double-blind, placebo-controlled Phase III clinical trial in 147 hospitals in 36 countries, recruited patients with advanced HER2-negative breast cancer aged 18 with BRCA1/2 embryo mutations, and required ECOG to perform 0-2 points and receive up to 2 lines of chemotherapy.
end point is progress-free survival.
July 30, 2014 - January 17, 2018, a total of 2,202 patients were screened, 513 of whom were included in the study.
337 patients in the intended treatment population (n-509) received veliparib combined carbotinol (veliparib group) and 172 received placebo combined carbotin-yew alcohol treatment (control group).
5 April 2019, the veliparib group and the control group followed 35.7 months (IQR 24.9-43.6) and 35.5 months (23.1-45.9) respectively, with a medium progress-free survival period of 14.5 Months (95% CI 12.5-17.7) and 12.6 months (10.6-14.4; risk ratio of 0.71, 95% CI 0.57-0.88; p=0.0016).
most common level 3 and above adverse reactions were neutral granulocyte reduction (81% in the veliparib group vs 84% in the control group), anemia (42% vs 40%) and plateiac reduction (40% vs 48%).
115 (34%) and 49 (29%) severe adverse reactions were also reported in the Veliparib group and the control group.
treatment-related deaths.
: This study shows that the addition of the PARP inhibitor veliparib to the highly active carpentry-yew alcohol program significantly and lastingly prolongs the progression-free survival of patients with advanced breast cancer with BRCA embryonic mutations.
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