Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

Phase 3

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Fulvestrant; Drug: 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.

Study Timeline

• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Study Start: 2007-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2017-12-13
• Results First Submitted QC: 2019-01-08
• Results First Posted: 2019-04-05
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 870

Inclusion Criteria

Not provided

Exclusion Criteria

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 Universitario Virgen de Los Lirios; 🇪🇸 Alcoy, Alicante, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital General Universitario de Elda; 🇪🇸 Elda, Alicante, Spain

Hospital Usp San Jaime; 🇪🇸 Torrevieja, Alicante, Spain

Hospital de Torrevieja Salud Ute; 🇪🇸 Torrevieja, Alicante, Spain

Hospital San Agustín de Avilés; 🇪🇸 Avilés, Asturias, Spain

Hospital Municipal de Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Institut Catalá D'Oncología L'Hospitalet; 🇪🇸 L'hospitalet de Llobregat, Barcelona, Spain

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