Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 2, 2020

Primary Completion Date

June 21, 2023

Study Completion Date

February 28, 2033

Conditions
Early Breast Cancer
Interventions
DRUG

Doxorubicin

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

DRUG

Cyclophosphamide

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

DRUG

Taxane

Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.

DRUG

Letrozole

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles

DRUG

Abemaciclib

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles

DRUG

LHRH Analogue

Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles

Trial Locations (28)

10003

Hospital Universitario San Pedro de Alcántara, Cáceres

12002

Consorcio Hospitalario Provincial de Castellón, Castellon

14004

Hospital Universitario Reina Sofía, Córdoba

15006

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

15706

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

17007

Institut Català d'Oncología (ICO) Girona, Girona

20014

Hospital Universitario Donostia, San Sebastián

23007

Complejo Hospitalario de Jaén, Jaén

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clínico San Carlos, Madrid

29010

Hospital Clínico Universitario Virgen de la Victoria, Málaga

30008

Hospital General Universitario Morales Meseguer, Murcia

36312

Hospital Álvaro Cunqueiro, Vigo

38010

Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

39008

Hospital Universitario Marqués de Valdecilla, Santander

41013

Hospital Universitario Virgen del Rocío, Seville

45004

Hospital Virgen de la Salud, Toledo

46009

Fundación Instituto Valenciano de Oncología (FIVO), Valencia

46010

Hospital Clínico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politécnic La Fe, Valencia

Hospital Universitario Reina Sofía, Valencia

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

Hospital Universitario Miguel Servet, Zaragoza

08908

Institut Català d'Oncología (ICO) L'Hospitalet, L'Hospitalet de Llobregat

03010

Hospital General Universitario de Alicante, Alicante

06080

Hospital Universitario de Badajoz, Badajoz

09006

Hospital Universitario de Burgos, Burgos

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Spanish Breast Cancer Research Group

OTHER