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The two proteins encoded by the BRCA1 and BRCA2 genes play a vital role in the DNA damage response, especially in the process of homologous recombination repair (HRR) double-stranded DNA breaks (DSB)
.
Tumors carrying germline mutations of these two genes (gBRCAmut) often have HRR defects and are therefore sensitive to PARP inhibitor treatment
This study aimed to evaluate the activity of the PARP inhibitor Niraparib for advanced breast cancer carrying gBRCAmut
.
BRAVO is a randomized, open-label phase 3 trial that recruits advanced breast cancer patients with gBRCAmut, HER2-negative, ≤2 previous treatments or recurrence 12 months after adjuvant chemotherapy, and randomized 2:1 to Nira Parli group (n=141) or chemotherapy group (PC; eribulin, capecitabine, vinorelbine or gemcitabine monotherapy, n=74)
.
The enrolled hormone receptor-positive patients have received ≥1 line of endocrine therapy and progressed during metastatic therapy or relapsed within 12 months after (new) adjuvant therapy
In the interim and final analysis, the PFS of the two groups
In the interim and final analysis, the PFS of the two groupsAfter the scheduled interim analysis, recruitment was stopped due to ineffectiveness
.
There is a high degree of inconsistency between the PC group’s local and the PFS assessed by the center, leading to information review
In the final analysis (median follow-up was 19.
OS of two groups
OS of two groupsThe median OS in the Nirapali group and PC group was 14.
5 months vs 15.
2 months (HR 0.
95, 95%CI 0.
63-1.
42, p=0.
79)
.
The objective response rates of the two groups were 35% (95% CI 26-45) and 31% (95% CI 19-46), respectively
The median OS of the Nirapali group and the PC group was 14.
Original source:
Original source:Nicholas C.
Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG / BIG5-13 / TESARO PR-30-50-10-C BRAVO Study in this message