Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole
- Registration Number
- NCT00543127
- Lead Sponsor
- Spanish Breast Cancer Research Group
- Brief Summary
Postmenopausal women with hormone receptor positive and negative Her2 tumours.
Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.
- Detailed Description
It is expected that disease-free survival for patients receiving Anastrozole alone for 5 years will be up to 90%. An increase of 3% in disease-free survival (DFS) is expected in the arm of Fulvestrant plus Anastrozole, i.e a DFS of up to 93%. They will be required 1358 patients per treatment group (i.e, 2716 patients in total) to give 80% power, alfa bilateral 0.05, and OR 0.6888. Assuming 5% screening failures 2852 patients are required to enter the study. In Jun-2010 the recruitment was stopped due to lack of support of the financier based on the result of Faslodex® and Arimidex® in Combination Trial (FACT-trial), comparing Fulvestrant + Anastrozole vs Anastrozole alone in 1st relapse showed no difference in time to progression at more than 40 months follow-up.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 870
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fulvestrant + Anastrozole Fulvestrant Fulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years Fulvestrant + Anastrozole Anastrozole Fulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years Anastrozole Anastrozole Anastrozole 1 mg will be administered orally as one tablet daily for 5 years.
- Primary Outcome Measures
Name Time Method Disease Free Survival (DFS) Events Up to 5 years Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.
DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.
- Secondary Outcome Measures
Name Time Method Breast Cancer Specific Survival (BCsS) Events Up to 5 years BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.
BCsS event is defined as the death from breast cancer.Time to Recurrence (TR) Event Up to 5 years TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.
TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause).Overall Survival (OS) Event Up to 5 years OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.
OS event is defined as the death from any cause.
Trial Locations
- Locations (53)
Hospital de Sagunto
🇪🇸Sagunto, Valencia, Spain
Hospital Lluís Alcanyis
🇪🇸Xátiva, Valencia, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Santa CRUZ DE Tenerife, Spain
Hospital Municipal de Badalona
🇪🇸Badalona, Barcelona, Spain
Hospital Usp San Jaime
🇪🇸Torrevieja, Alicante, Spain
Hospital General Universitario de Elda
🇪🇸Elda, Alicante, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
Hospital San Agustín de Avilés
🇪🇸Avilés, Asturias, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital de Torrevieja Salud Ute
🇪🇸Torrevieja, Alicante, Spain
Hospital Universitario Virgen de Los Lirios
🇪🇸Alcoy, Alicante, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitari Germans Trias I Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital de Barbastro
🇪🇸Barbastro, Huesca, Spain
Institut Catalá D'Oncología L'Hospitalet
🇪🇸L'hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón
🇪🇸Castellón de La Plana, Castellón, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
🇪🇸Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hospital Donostia
🇪🇸Donostia-san Sebastián, Guipúzcoa, Spain
Onkologikoa
🇪🇸Donostia-san Sebastián, Guipúzcoa, Spain
Hospital Universitario de Valme
🇪🇸Dos Hermanas, Sevilla, Spain
Centro Oncológico de Galicia
🇪🇸A Coruña, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Complejo Hospitalario Torrecárdenas
🇪🇸Almería, Spain
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
HOSPITAL UNIVERSITARI DE GIRONA DR. JOSEP TRUETA (ICO de Girona)
🇪🇸Girona, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Hospital General Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital Universitario Arnau de Vilanova de Lleida
🇪🇸Lleida, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
CENTRO INTEGRAL ONCOLÓGICO CLARA CAMPAL (Hospital Madrid Norte Sanchinarro)
🇪🇸Madrid, Spain
Hospital Universitario Ramón Y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Clínico Universitario Virgen de La Victoria
🇪🇸Malaga, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Del Rocío
🇪🇸Sevilla, Spain
Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Virgen de La Salud
🇪🇸Toledo, Spain
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Arnau de Vilanova de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain