First Patient In DxCARTES study

MedSIR has enrolled the first patient in DxCARTES: Neoadjuvant letrozole and palbociclib in patients with stage II-IIIB breast cancer, HR[+]/HER2[-] phenotype and pre-treatment Recurrence Score® (RS) result 18-25 or 26-100 by the Oncotype Dx breast RS assay. Analysis of RS and Pathological changes at surgery.

This first patient has been enrolled at site Hospital Arnau de Vilanova de Valencia, Spain and started to receive the study treatment on 28-May-2019.

DxCARTES study 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.

This trial will enroll a total of 66 patients in 2 European countries (Spain and Portugal) during an estimated recruitment period of 24 months.

The primary objective is 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.

Secondary objectives are to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by post-treatment RS result, in patients with aggressive luminal tumors (pre-treatment RS result 18-25 and Ki67≥ 20) after 6 months of treatment. To explore the ability of palbociclib in combination with letrozole to induce global molecular reduction measured by either the post-treatment RS result, and/or Residual Cancer Burden (RCB), and/or Ki67 in patients with aggressive luminal tumors (pre-treatment RS result 18-25 or 26-100 and Ki67 ≥ 20) after 6 months of treatment, to induce global molecular reduction (measured as either post-treatment RS≤25 or RCB score of 0-I) in >35% of patients in cohort B with pre-treatment RS 26-100; verify the ability of palbociclib in combination with letrozole to induce increase in RS result (measured as post-treatment RS 26-100) in <3% of patients in cohort A with pre-treatment RS 18-25; and determine the change in RS result as measured by median absolute value or median percentage after 6 months of treatment: from pre-treatment RS 18-25 to post-treatment RS 0-17 for patients in cohort A and from pre-treatment RS 26-100 to post-treatment RS≤25 for patients in cohort B.

The study is currently approved in Spain. We expect to receive all the regulatory approvals in Portugal within the upcoming weeks.

We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of DxCARTES study.

Author: Laura Calabuig