A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
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 as determined by
Clinical Benefit Rate (CBR) using the Response Evaluation Criteria in Solid Tumors (RECIST
1.1).
In the first stage Triple negative (TN) non-BRCA, metastatic breast cancer (MBC) patients
whose tumours exhibited any characteristic related to homologous recombination deficiency
(HRD). In the second stage, luminal patients (RH positive HER2 negative) will be allowed in
the same conditions that TN.
Patients whose tumours are identified as Homologous Recombination Deficient by deleterious
HRR gene mutations (according to Foundation Medicine's Foundation One assay) will receive
olaparib 300 mg (two tablets of 150mg) orally twice daily (bid) on days 1-28 each 28 days.
Study commitment is 39 patients: 17 patients will be enrolled at first stage and 22 at the
second stage.
The total duration of the study period is 34 months.