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

August 14, 2019 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil, 14784-400
        • Research Site
      • Belo Horizonte, Brazil, 30380-490
        • Research Site
      • Goiânia, Brazil, 74000-000
        • Research Site
      • Jaú, Brazil, 17210-120
        • Research Site
      • Rio de Janeiro, Brazil, 20560-120
        • Research Site
      • Sao Paulo, Brazil, 01219-010
        • Research Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Plovdiv, Bulgaria, 4000
        • Research Site
      • Shumen, Bulgaria, 9700
        • Research Site
      • Sofia, Bulgaria, 1784
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
      • Sofia, Bulgaria, 1233
        • Research Site
      • Varna, Bulgaria, 9000
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Research Site
      • Vratza, Bulgaria, 3000
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Jicin, Czechia, 506 43
        • Research Site
      • Ostrava, Czechia, 708 52
        • Research Site
      • Praha 4, Czechia, 140 00
        • Research Site
      • Usti nad Labem, Czechia, 401 13
        • Research Site
  • France
      • Nice, France, 06100
        • Research Site
      • Poitiers, France, 86000
        • Research Site
      • Saint-cloud, France, 92210
        • Research Site
  • Italy
      • Napoli, Italy, 80131
        • Research Site
      • Sassari, Italy, 07100
        • Research Site
  • Poland
      • Kraków, Poland, 31-115
        • Research Site
      • Olsztyn, Poland, 10-228
        • Research Site
  • Spain
      • Barcelona, Spain, 08003
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • Córdoba, Spain, 14004
        • Research Site
      • Lérida, Spain, 25198
        • Research Site
      • Pontevedra, Spain, 36002
        • Research Site
  • United Kingdom
      • Derby, United Kingdom, DE22 3DT
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
  • United States
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63113
        • Research Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Research Site
    • Texas
      • Austin, Texas, United States, 78705
        • Research Site
      • Duncanville, Texas, United States, 75137
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Fulvestrant
Drug: fulvestrant
500 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Active Comparator: 2
Anastrozole
Drug: anastrozole
1 mg oral tablet
Other Names:
  • ZD1033
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Rate
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 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.
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 to Progression
Time Frame: 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.
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 to Treatment Failure
Time Frame: 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
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 to Progression (Investigator Assessed)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2006

Primary Completion (Actual)

January 10, 2008

Study Completion (Actual)

January 13, 2017

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6995C00006
  • FIRST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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