DxCARTES

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Neoadyuvant Letrozole and Palbociclib in patients with Stage II-IIB Breast Cancer, HR (+), HER2 (-) phenotype and pre-treatment recurrence Score (RS) result 18-25 or 26-100 by Oncotype DX Breast RS assay. Analysis of RS and pathological changes at surgery.

This is an international, open-label, multicenter phase II clinical trial primary objective: To explore after 6 months of treatment 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 (pre-treatment RS result 18-25 or 26-100, and Ki67>20).

NAME TUMOR TYPE TITLE PHASE N SITES COUNTRY STATUS
DXCARTES
Breast Neoadyuvant Letrozole and Palbociclib in patients with Stage II-IIB Breast Cancer, HR (+), HER2 (-) phenotype and pre-treatment recurrence Score (RS) result 18-25 or 26-100 by Oncotype DX Breast RS assay. Analysis of RS and pathological changes at surgery. II 66 First stage: 20 Sites, Second stage: 25 sites, Total Sites 25 First stage:Spain, Portugal
Second stage: Spain, Portugal,France
Submitted to Spain, approved from CEIm and AEMPS.