Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

PHASE2CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

July 13, 2017

Primary Completion Date

June 10, 2019

Study Completion Date

July 20, 2019

Conditions
Breast Cancer
Interventions
DRUG

Ribociclib

Ribociclib flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.

DRUG

Letrozole 2.5mg

Daily continuous

DRUG

Doxorubicin

60 mg/m2 as a continuous IV perfusion

DRUG

Cyclophosphamide

600 MG/M2 in a 30 minutes IV infusion

DRUG

Paclitaxel

80 mg/m2, in one hour IV infusion

Trial Locations (21)

Unknown

Hospital Clinic de Barcelona, Barcelona

Hospital General de Catalunya, Barcelona

Hospital Universitari Vall d' Hebron, Barcelona

Institut Català d'Oncologia l'Hospitalet, Barcelona

Consorcio Hospitalario Provincial de Castellón, Castelló

Hospital San Pedro de Alcántara, Cáceres

Fundació Privada Hospital Asil de Granollers, Granollers

Centro Integral Oncologico Clara Campal, Madrid

Centro Oncológico MD Anderson International España, Madrid

Hospital Quirón Madrid, Madrid

Hospital Rey Juan Carlos, Madrid

Hospital Universitario 12 de octubre, Madrid

Hospital Universitario Fundación de Alcorcón, Madrid

Hospital Universitario Fundación Jiménez Díaz, Madrid

Hospital Universitari Son Espases, Palma

Complexo Hospitalario Universitario de Santiago, Santiago de Compostela

Hospital Virgen del Rocío, Seville

Hospital Virgen Macarena, Seville

Fundación Instituto Valenciano de Oncología, Valencia

Hospital Clínico Universitario de Valencia, Valencia

Hospital Universitari Arnau de Vilanova de València, Valencia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

SOLTI Breast Cancer Research Group

OTHER

NCT03248427 - Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer. | Biotech Hunter | Biotech Hunter