NCT00635713

Brief Summary

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1997

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
Last Updated

April 10, 2009

Status Verified

April 1, 2009

First QC Date

March 7, 2008

Last Update Submit

April 9, 2009

Conditions

Advanced Breast Cancer

Keywords

Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal

Outcome Measures

Primary Outcomes (1)

  • time to tumor progression

    Every 3 months

Secondary Outcomes (3)

  • objective tumor response

    Every 3 months

  • time to treatment failure

    Every 3 months

  • time to death

    Every 3 months

Study Arms (2)

1

EXPERIMENTAL

Faslodex 125mg and Arimidex 1 mg

Drug: FulvestrantDrug: Anastrozole

2

EXPERIMENTAL

Faslodex 250mg and Arimidex 1mg

Drug: AnastrozoleDrug: Fulvestrant

Interventions

FulvestrantDRUG

125mg

Also known as: Faslodex
1
AnastrozoleDRUG

ARIMIDEX

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal women with confirmation of breast cancer
  • objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

You may not qualify if:

  • presence of life-threatening metastatic visceral disease
  • previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
  • more than 1 prior endocrine medical treatment for advanced breast cancer .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FulvestrantAnastrozole

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Guido Hoctin-Boes

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 14, 2008

Study Start

May 1, 1997

Study Completion

September 1, 2004

Last Updated

April 10, 2009

Record last verified: 2009-04