A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer

Metastatic Breast Cancer Clinical Trial

— FIRST  

Official title:

A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274469
• Other study ID #: D6995C00006
• Secondary ID: FIRST
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2006
• Est. completion date: January 13, 2017

Study information

• Verified date: August 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: January 13, 2017
• Est. primary completion date: January 10, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 100 Years

Eligibility

Inclusion Criteria:

• Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

Exclusion Criteria:

• Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• fulvestrant
500 mg intramuscular injection
• anastrozole
1 mg oral tablet

Locations

Country	Name	City	State
Brazil	Research Site	Barretos
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Goiânia
Brazil	Research Site	Jaú
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Shumen
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo
Bulgaria	Research Site	Vratza
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Jicin
Czechia	Research Site	Ostrava
Czechia	Research Site	Praha 4
Czechia	Research Site	Usti nad Labem
France	Research Site	Nice
France	Research Site	Poitiers
France	Research Site	Saint-cloud
Italy	Research Site	Napoli
Italy	Research Site	Sassari
Poland	Research Site	Kraków
Poland	Research Site	Olsztyn
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Córdoba
Spain	Research Site	Lérida
Spain	Research Site	Pontevedra
United Kingdom	Research Site	Derby
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Edinburgh
United States	Research Site	Austin	Texas
United States	Research Site	Duncanville	Texas
United States	Research Site	Frederick	Maryland
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Czechia,  France,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate	A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Secondary	Objective Response Rate	For each patient with measurable disease at baseline, the determination of the overall response for each visit was carried out using a SAS program per Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesion (TL) and non-target lesions (NTLs) and no new lesions. Partial Response (PR): At least a 30% decrease in the sum of longest diameter of TLs (compared to baseline), no progression of NTLs and no new lesions. Objective response rate is defined as percentage of patients with either CR or PR.	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Secondary	Time to Progression	Time from randomization until earlier of disease progression or death. Progression was defined according to RECIST: a patient is determined to have progressed if they have progression of target lesions, clear progression of existing non-target lesions, or the appearance of one or more new lesions. Progression of target lesions is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum of LD recorded. Kaplan-Meier estimates of median for each treatment are reported.	From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Secondary	Time to Treatment Failure	Time from randomization to treatment discontinuation	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Secondary	Time to Progression (Investigator Assessed)	Time from randomization to disease progression (investigator assessed) or death from any cause. Progression was defined by investigator opinion, as patients did not have formal RECIST visits in the follow-up period after the data cut off for the primary analysis of the study.	From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.

External Links

•   CSR-D6995C00006.pdf
•   D6995C00006FIRSToverall_survivalRevisedCSP_4_10_December_2014_Redacted