First Patient in OPHELIA Study
Another trial opens its recruitment and this time, in the Ophelia study. The first patient randomized was at Hospital San Carlos, Madrid, and the patient started to receive the study treatment on the 7th of August.
Ophelia study is a phase II trial, multicenter, single-arm, two-cohort, Simon’s two-stage minimax design focused on evaluate the efficacy and safety of olaparib plus trastuzumab in patients with HER2[+], BRCA-mutated or wild-type BRCA/HRD advanced breast cancer.
In order to be included in the cohort A of the study, patients must exhibit germinal deleterious mutations in BRCA1 or BRCA2 genes. In the second stage of the study, patients must show wild-type germinal BRCA1/2 genes with HRD positive status based on HRDetect test, in order to be included in the exploratory cohort B.
Eligible patients have a histologically proven diagnosis of adenocarcinoma of the breast with evidence of advanced disease, and at least one measurable disease as per RECIST v.1.1. Patients will have a documented history of progression on HER2-directed therapy for the treatment of HER2-positive breast cancer with not more than three prior regimens of chemotherapy and/or trastuzumab-lapatinib in advanced scenario, and at least one regimen of chemotherapy including trastuzumab.
The primary objective is to assess the efficacy – as determined by the Overall Response Rate (ORR) and Progression-free Survival (PFS) based on RECIST v.1.1 – of olaparib in combination with trastuzumab in patients with HER2-positive, germinal BRCA1/2 mutated ABC.
The accrual goal will be a total of 20 patients in Spain during an estimated recruitment period of 24 months: 7 patients in the first stage and 13 patients in the second stage. Additionally, in the second stage, the investigators will accrual 13 patients on the exploratory cohort B.
The study is currently approved in Spain and all participant sites are activated.
We are very glad about the effort and dedication of Dr. Garcia Saenz and his team and, of course, we highly appreciate the whole investigator team’s involvement in the set-up procedure of OPHELIA study.