Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

February 3, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

February 28, 2026

Conditions
Breast CancerHER2-negative Breast CancerHormone Receptor Positive TumorPremenopausal Breast Cancer
Interventions
DRUG

Elacestrant

Elacestrant 400 mg given orally on a daily and continuous basis for 30 days or until the day before surgery or biopsy (+7 extra days).

DRUG

Triptorelin

Monthly triptorelin 3.75 mg powder and solvent for prolonged-release suspension for injection. Each vial contains 3.75 mg of triptorelin (acetate). After reconstitution with 2 ml of solvent, 1 ml of the suspension contains 1.875 mg triptorelin. This drug contains sodium, but less than 1 mmol (23 mg) of sodium per vial.Triptorelin will be administrated on D1 and D29.

Trial Locations (9)

10003

Complejo Hospitalario San Pedro de Alcántara, Cáceres

08035

Hospital Universitari Vall d'Hebron, Barcelona

Unknown

Hospital Universitario Virgen de la Arrixaca, El Palmar

Hospital Clinic de Barcelona, Barcelona

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario Central de Asturias, Oviedo

Complejo Hospitalario de Navarra, Pamplona

Hospital Universitari General de Catalunya, Sant Cugat del Vallès

Hospital Clínico de Valencia, Valencia

All Listed Sponsors
lead

SOLTI Breast Cancer Research Group

OTHER