DXCARTES
OFFICIAL TITLE: 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.
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SCIENTIFIC IMPACT
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TRIAL RESUME
DXCARTES SITES
CLINICAL TRIAL DETAILS
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).
DXCARTES AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
BREAST
II
66
16
Spain
N
SITES
COUNTRY
STATUS
Closing
SPAIN
Instituto Valenciano de Oncología (IVO)
SPAIN
Hospital Clínico Universitario de Valencia
SPAIN
Institut Català d' Oncologia L'Hospitalet (ICO)
SPAIN
Hospital Arnau de Vilanova de Valencia
SPAIN
Hospital Universitario Arnau de Vilanova de Lleida
SPAIN
Hospital Universitario Reina Sofía
SPAIN
Hospital Universitario Ramón y Cajal
SPAIN
Hospital Universitario Virgen de la Victoria
SPAIN
Instituto Oncológico Baselga - Hospital Quiron Salud Barcelona
SPAIN
Onkologikoa
SPAIN
Institut Català d' Oncologia Badalona (ICO)
SPAIN
Hospital Universitario Miguel Servet
SPAIN
Hospital Universitario Virgen del Rocío
SPAIN
Hospital del Mar
SPAIN
Complejo Hospitalario de Jaén
SPAIN
Hospital Universitari Vall D'Hebron