NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 25, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

July 31, 2030

Conditions
Breast Cancer
Interventions
DRUG

Patritumab deruxtecan

HER3-DXd will be administered as Lyo-DP, a sterile lyophilized powder in a dose of 5.6 mg/kg

DRUG

Chemotherapy

Anthracycline/taxane-based neoadjuvant regimen recommended by the NCCN or local guidelines. i.e. EC or AC (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 every 14 or 21 days) followed by weekly paclitaxel 80mg/m2 during 12 weeks

DRUG

Letrozole

Letrozole and LHRH will be used following SmPC specifications, according to standard therapy and clinical studies

Trial Locations (25)

10003

Complejo Hospitalario San Pedro de Alcántara, Cáceres

14004

Hospital Universitario Reina Sofia, Córdoba

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

18014

Hospital Universitario Virgen de las Nieves, Granada

28222

Hospital Universitario Puerta de Hierro de Majadahonda, Madrid

28933

Hospital Universitario Rey Juan Carlos, Móstoles

30120

Hospital Universitario Virgen de la Arrixaca, Murcia

38320

Hospital Universitario de Canarias, Santa Cruz de Tenerife

43204

Hospital Sant Joan de Reus, Reus

08916

ICO Badalona, Badalona

Unknown

Hospital Universitario de Fuenlabrada, Fuenlabrada

Hospital General de Catalunya, Barcelona

Hospital Universitari Vall d' Hebrón, Barcelona

Hospital de Basurto, Bilbao

H.Univ. Arnau de Vilanova de Lleida, Lleida

Hospital Universitario 12 de Octubre, Madrid

HAU de Manresa, Manresa

Hospital Son Espases, Palma de Mallorca

HU Parc Tauli, Sabadell

Comp. Hosp.Univ. Santiago (Chus), Santiago de Compostela

Hospital Universitario Virgen del Rocio, Seville

H La Fe, Valencia

Hospital Clínico de Valencia, Valencia

06080

Hospital Universitario de Badajoz, Badajoz

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

SOLTI Breast Cancer Research Group

OTHER