Official Title: A two-stage Simon Design phase II study for NOn-BRCA MBC patients with homologous recombination deficiency (HRD) treated with OLAparib single agent.
This is an international, multi-centre, non-controlled, open-label, single arm, two-stage Simon Design phase II study for non-BRCA metastatic breast cancer (MBC) patients with homologous recombination deficiency treated with Olaparib single agent.
The main objective is to assess the efficacy of olaparib single agent in non-BRCA metastatic breast cancer (MBC) patients whose tumours exhibit any characteristic related to homologous recombination deficiency (HRD), as determined by Clinical Benefit Rate (CBR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
With an expected duration of 34 months, the study commitment is 39 patients: 17 patients will be enrolled at the first stage and 22 at the second stage.
NOBROLA at clinicaltrials.gov