Spots Global Cancer Trial Database for A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
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Trial Identification
Brief Title: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
Official Title: A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer
Study ID: NCT05896566
Conditions
Study Description
Brief Summary: PREcoopERA is a randomized (2:2:1), multicenter, open-label, three-arm (A, B, C), Window-of-Opportunity (WOO) trial to evaluate the activity and safety of giredestrant (A) versus giredestrant plus triptorelin (B) versus anastrozole plus triptorelin (C).
Detailed Description: The primary objectives are: * to determine if 4 weeks of giredestrant plus triptorelin provides greater anti-proliferative activity than anastrozole plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer. * to determine if 4 weeks of giredestrant without triptorelin provides anti-proliferative activity that is similar (non-inferior) to giredestrant plus triptorelin among premenopausal patients with ER-positive/HER2-negative operable invasive breast cancer.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Gustave Roussy Cancer Center, Villejuif, , France
HELIOS Klinikum Berlin Buch, Berlin, , Germany
Praxisklinik Krebsheilkunde formerly MediOnko-Institut GbR, Berlin, , Germany
KEM / Kliniken Essen Mitte, Essen, , Germany
Klinikum der J. W. Goethe Universität, Frankfurt, , Germany
Universitätsklinikum Schleswig-Holstein, Kiel, , Germany
St. Elisabeth Krankenhaus, Leipzig, , Germany
Universitätsklinikum Mannheim GmbH, Mannheim, , Germany
Klinikum Südstadt, Rostock, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Helios Klinikum Wuppertal GmbH, Wuppertal, , Germany
National Institute of Oncology, Budapest, , Hungary
Cork University Hospital, Cork, , Ireland
St. James Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Clinica Oncologica AOU Riuniti Ancona, Ancona, , Italy
Humanitas Gavazzeni, Bergamo, , Italy
ASL BR Azienda Sanitaria Locale, Brindisi, , Italy
IRCCS Ospedale Policlinico San Martino, Genova, , Italy
Istituto oncologico romagnolo per lo studio dei tumori "Dino Amadori", Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
AOU maggiore della carita, Novara, , Italy
Istituti Clinici Scientifici Maugeri SpA-SB, Pavia, , Italy
Azienda USL Toscana Centro, Prato, , Italy
Rimini Oncology department, Rimini, , Italy
Fondazione Policlinico Gemelli Medical Oncology Unit, Roma, , Italy
Policlinico universitario Agostino Gemelli IRCCS Rome, Roma, , Italy
Complejo Hospitalario Universitario Badajoz, Badajoz, , Spain
Institut Catala D'oncologia ICO-Badalona, Badalona, , Spain
Institut Catala d'Oncologia - Hospitalet, Barcelona, , Spain
H.U. Arnau de Vilanova de Lleida, Lleida, , Spain
CIOCC (Centro Integral Oncológico Clara Campal), Madrid, , Spain
Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
H. la Fé, Valencia, , Spain
Sahlgrenska Comprehensive Cancer Center, Gothenburg, , Sweden
Kantonsspital Baden AG, Baden, , Switzerland
Praxis Dr. Thorn, Praxis fur ambulante Tumortherapie (Praxis Thorn (Bethesda)), Basel, , Switzerland
Onc Inst of Southern Switzerland (IOSI), Bellinzona, , Switzerland
Centre du Sein (Hopital Fribourgeois-Freiburger Spital), Fribourg, , Switzerland
La Chaux-de-fonds, RH Neuchatelois (Hopital Les Cadolles), La Chaux-de-Fonds, , Switzerland
St. Anna Hirslanden, Luzern, , Switzerland
Brustzentrum Thurgau ( Spital AG), Thurgau, , Switzerland
Universitiy Hospital Zurich, Zürich, , Switzerland
Contact Details
Name: Elisabetta Munzone, MD
Affiliation: European Institute of Oncology, Milano
Role: STUDY_CHAIR
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