EMPRESS
OFFICIAL TITLE: PREOPERATIVE WINDOW OF OPPORTUNITY STUDY WITH GIREDESTRANT (GDC-9545) OR TAMOXIFEN IN PREMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR-POSITIVE/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE AND KI67≥10% EARLY BREAST CANCER.
ER+/HER2- Ki67≥10% Early Breast Cancer
II
92
20
Spain, France
Set-up
CLINICAL TRIAL DETAILS
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.
EMPRESS AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
TRIAL RESUME
EMPRESS SITES
SPAIN
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 Ubiversitari 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 Universitari Sant Joan de Reus
SPAIN
Hospital Clínic I Provincial de Barcelona
SPAIN
Hospital Ruber Internacional
SPAIN
Hospital Universitario Ramón y Cajal
SPAIN
Hospital Universitario de León
FRANCE
Hospital Europeen Georges Pompidou
FRANCE
Hôpital Tenon AP-HP