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EMPRESS

GIREDESTRANT (GDC-9545) OR TAMOXIFEN IN ER+/HER2- Ki67≥10% EARLY BREAST CANCER

THE PRIMARY OBJECTIVE IS TO ASSESS CHANGES IN TUMOR CELL PROLIFERATION AS MEASURED BY KI67 EXPRESSION BETWEEN BASELINE AND POST-TREATMENT TUMOR BIOPSY SAMPLES BY CENTRAL ASSESSMENT IN PATIENTS WITH CENTRALLY CONFIRMED KI67>10% IN GIREDESTRANT VS. TAMOXIFEN. IN ADDITION, THE STUDY WILL MEASURE COMPLETE CELL CYCLE ARREST, ANALYZE CHANGES IN ER AND PGR LEVELS, COMPLETE MOLECULAR PROFILING USING HTG, AND EVALUATE TOXICITY.

COUNTRY

STATUS

TUMOR TYPE

PHASE

N

SITES

ER+/HER2- Ki67≥10% Early Breast Cancer

20

92

II

Spain, France

Closing

CLINICAL TRIAL DETAILS

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Instituto Valenciano de Ocología (Spain) | Hospital Clínic i Provincial de Barcelona (Spain) | Hospital Clínico Universitario de Valencia (Spain) | Hospital Arnau de Vilanova de Valencia (Spain) | Hospital General Universitario Dr. Balmis (Spain) | Hospital Universitari Dexeus (Spain) | Hospital Universitari San Joan de Reus (Spain) | Hospital Universitario de Navarra (CUN) (Spain) | Hospital Universitario de Basurto (Spain) | Institut Català d’ Oncologia Badalona (Spain) | Hospital Ruber Internacional (Spain) | Hospital Universitario Ramón y Cajal (Spain) | Hospital Universitario de León (Spain) | Hospital Europeen Georges Pompidou (France) | Hôpital Tenon AP-HP (France)
Dr. Cortes and Dr. Llombart PHERain interview
Beyond Chemotherapy
Dr. Vanes Quiroga
Dr. Sofia Braga
Dr. Silvi Antolín
Dr. Escrivá de Romaní
Dr. Philipp Aftimos
Dr. Manuel Ruiz
Prof. Daniele Generali PHEGain interview
Dr. Jacques Medioni
Dr. Dunca Wheatley
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