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OpenTrials
Completed

NCT Number: NCT00635713

Second Line Breast Cancer Trial

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.

Completed

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Fulvestrant

Drug

125mg

Other names: Faslodex

Anastrozole

Drug

ARIMIDEX

Primary outcomes

  1. time to tumor progression

    Time frame: Every 3 months

Secondary outcomes

  1. objective tumor response

    Time frame: Every 3 months

  2. time to treatment failure

    Time frame: Every 3 months

  3. time to death

    Time frame: Every 3 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
1997
Study completion
2004
First posted
Mar 14, 2008
Registry last updated
Apr 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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