
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
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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