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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: anastrozole; Drug: fulvestrant

• Registration Number: NCT00274469
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Study Start: 2006-02-06
• Primary Completion: 2008-01-10
• Results First Submitted: 2009-01-27
• Results First Submitted QC: 2009-06-26
• Results First Posted: 2009-08-12
• Study Completion: 2017-01-13
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	anastrozole	Anastrozole
1	fulvestrant	Fulvestrant

Primary Outcome Measures

Name	Time	Method
Clinical Benefit Rate	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.	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.

Secondary Outcome Measures

Name	Time	Method
Time to Progression	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.	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.
Time to Treatment Failure	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.	Time from randomization to treatment discontinuation
Objective Response Rate	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.	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.
Time to Progression (Investigator Assessed)	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.	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Edinburgh, United Kingdom