A Two-stage Simon Design Phase II Study for NOn-BRCA Metastatic BReast Cancer (MBC) Patients With Homologous Recombination Deficiency 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).
In the first stage, subjects recruited will be Triple negative (TN) non-BRCA metastatic breast cancer (MBC) patients whose tumours exhibit any characteristic related to homologous recombination deficiency (HRD), according to Foundation Medicine’s Lynparza HRR assay. In the second stage, luminal patients (RH positive HER2 negative) will also be allowed in the same conditions that TN patients.
Recruited subjects will receive olaparib 300 mg (two tablets of 150mg) orally twice daily (bid) on days 1-28 of 28-day cycles.
Study commitment is 39 patients: 17 patients will be enrolled at the first stage and 22 at the second stage. There will be an interim analysis at the end of stage I to check if there is clinical benefit in at least one patient. Interim analysis result will have to be positive in order to proceed with stage II.
Total study duration is expected to be 34 months.