An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2- metastatic breast cancer patients with high genomic loss of heterozygosity.

Congress : ASCO

Authors : A. Patsouris, O. Tredan, L.Campion, A. Gonçalves, M. Arnedos, MP. Sablin, P. Jezequel, M. Jimenez, V. Pezzella, I. Bieche, C. Callens, A.Loehr, D. Nenciu, C. Vicier, F. André

Experts group or program : Médecine personnalisée


Rucaparib, a potent oral PARP-1, -2 and -3 inhibitor, has shown activity in a phase 3 study in patients (pts) with ovarian carcinoma (ARIEL 3) harbouring a BRCA mutation or an homologous recombination deficient (HRD) profile defined by high percentage of genome-wide loss of heterozygosity and in a phase 1 study that included breast cancer pts with germline BRCA mutation (Kristeleit et al, Clin Can Res, 2017). High genomic LOH score identified HRD tumors (also known as BRCAness tumors), including both known BRCA1 methylation and unknown genetic/epigenetic mechanisms and somatic BRCA1/2 mutations. This single arm, open-label, multicenter phase II RUBY study (NCT02505048) is evaluating the efficacy and safety of rucaparib in pts with HER2- metastatic breast cancer (MBC) associated with a “high tumor genomic LOH” score and/or a somatic BRCA mutation (excluding BRCA1 and/or BRCA2 germline mutation).


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