MedSIR is delighted to announce that DxCARTES study achieves a new milestone: 50% recruitment completed in stage 1. We currently have 15 patients recruited and 39 screenings have been sent to Central lab:
11 Screening Failures
8 patients at Cohort A
8 patients at Cohort B
19 Screening pending to be analyzed
DxCARTES is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial with the objective to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by either the Oncotype DX Breast Recurrence Score® (the “Assay”) test result at surgery (post-treatment Recurrence Score (RS) result), or pathological Complete Response (pCR) in patients with aggressive luminal tumors (intermediate or high pre-treatment RS result and Ki67>20) after 6 months of treatment.
We will continue working on study recruitment until we achieve a total of 26 patients enrolled in the first stage.
The study is currently approved in Spain but we expect to receive all the regulatory approvals from Portugal during July.
Thank you very much for the effort to all parties involved.
Author: Laura Calabuig