Second Line Breast Cancer Trial

A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635713

Enrollment

588

Registered

2008-03-14

Start date

1997-05-31

Completion date

2004-09-30

Last updated

2009-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Keywords

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

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.

Interventions

DRUGFulvestrant

125mg

DRUGAnastrozole

ARIMIDEX

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 .

Design outcomes

Primary

Measure	Time frame
time to tumor progression	Every 3 months

Secondary

Measure	Time frame
objective tumor response	Every 3 months
time to treatment failure	Every 3 months
time to death	Every 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026