A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

January 23, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions
Breast Cancer
Interventions
DRUG

Giredestrant

Giredestrant: 30 mg daily, PO from day 1 until the day of re-biopsy/surgery.

DRUG

Triptorelin

Triptorelin: 3.75 mg IM on day 1. Note: If re-biopsy/surgery cannot be done on day 29 (±3 days) from the first injection, then a second dose of triptorelin should be given on day 29 (±3 days).

DRUG

Anastrozole

Anastrozole: 1 mg daily, PO from day 1 until the day of re-biopsy/surgery.

Trial Locations (44)

Unknown

NOT_YET_RECRUITING

Gustave Roussy Cancer Center, Villejuif

RECRUITING

HELIOS Klinikum Berlin Buch, Berlin

RECRUITING

Praxisklinik Krebsheilkunde formerly MediOnko-Institut GbR, Berlin

RECRUITING

KEM / Kliniken Essen Mitte, Essen

RECRUITING

Klinikum der J. W. Goethe Universität, Frankfurt

NOT_YET_RECRUITING

Universitätsklinikum Schleswig-Holstein, Kiel

RECRUITING

St. Elisabeth Krankenhaus, Leipzig

RECRUITING

Universitätsklinikum Mannheim GmbH, Mannheim

RECRUITING

Klinikum Südstadt, Rostock

NOT_YET_RECRUITING

Universitätsklinikum Ulm, Ulm

RECRUITING

Helios Klinikum Wuppertal GmbH, Wuppertal

RECRUITING

National Institute of Oncology, Budapest

NOT_YET_RECRUITING

Cork University Hospital, Cork

RECRUITING

St. James Hospital, Dublin

NOT_YET_RECRUITING

University Hospital Galway, Galway

RECRUITING

Clinica Oncologica AOU Riuniti Ancona, Ancona

RECRUITING

Humanitas Gavazzeni, Bergamo

NOT_YET_RECRUITING

ASL BR Azienda Sanitaria Locale, Brindisi

RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

RECRUITING

"Istituto oncologico romagnolo per lo studio dei tumori Dino Amadori", Meldola

RECRUITING

Istituto Europeo di Oncologia, Milan

RECRUITING

AOU maggiore della carita, Novara

NOT_YET_RECRUITING

Istituti Clinici Scientifici Maugeri SpA-SB, Pavia

RECRUITING

Azienda USL Toscana Centro, Prato

RECRUITING

Rimini Oncology department, Rimini

NOT_YET_RECRUITING

Fondazione Policlinico Gemelli Medical Oncology Unit, Roma

NOT_YET_RECRUITING

Policlinico universitario Agostino Gemelli IRCCS Rome, Roma

RECRUITING

Complejo Hospitalario Universitario Badajoz, Badajoz

RECRUITING

Institut Catala D'oncologia ICO-Badalona, Badalona

RECRUITING

Institut Catala d'Oncologia - Hospitalet, Barcelona

RECRUITING

H.U. Arnau de Vilanova de Lleida, Lleida

RECRUITING

CIOCC (Centro Integral Oncológico Clara Campal), Madrid

RECRUITING

Fundación Jiménez Díaz, Madrid

RECRUITING

Hospital Universitari Son Espases, Palma de Mallorca

RECRUITING

H. la Fé, Valencia

RECRUITING

Sahlgrenska Comprehensive Cancer Center, Gothenburg

RECRUITING

Kantonsspital Baden AG, Baden

RECRUITING

Praxis Dr. Thorn, Praxis fur ambulante Tumortherapie (Praxis Thorn (Bethesda)), Basel

RECRUITING

Onc Inst of Southern Switzerland (IOSI), Bellinzona

RECRUITING

Centre du Sein (Hopital Fribourgeois-Freiburger Spital), Fribourg

RECRUITING

La Chaux-de-fonds, RH Neuchatelois (Hopital Les Cadolles), La Chaux-de-Fonds

RECRUITING

St. Anna Hirslanden, Lucerne

RECRUITING

Brustzentrum Thurgau ( Spital AG), Thurgau

RECRUITING

Universitiy Hospital Zurich, Zurich

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

ETOP IBCSG Partners Foundation

NETWORK