Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT00099437

This clinical trial evaluates the efficacy of 500 mg versus 250 mg Fulvestrant in postmenopausal women with estrogen receptor-positive advanced breast cancer, progressing after prior endocrine therapy. Eligible participants must have evidence of hormone sensitivity and provide informed consent. Fulvestrant is administered via intramuscular injection.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.

Eligibility Criteria

Inclusion Criteria

  • Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
  • Requiring hormonal treatment
  • Postmenopausal women defined as a woman who has stopped having menstrual periods
  • Evidence of positive estrogen receptor hormone sensitivity
  • Written informed consent to participate in the trial

Exclusion Criteria

  • Treatment with an investigational or non-approved drug within one month
  • An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
  • A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil)
  • Treatment with more than one regimen of chemotherapy for advanced breast cancer
  • Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Locations

FACILITYZIPCITYSTATE
Research Site85122Casa GrandeArizona
Research Site92708Fountain ValleyCalifornia
Research Site06052New BritainConnecticut
Research Site34429Crystal RiverFlorida
Research Site33308Fort LauderdaleFlorida
Research Site61801UrbanaIllinois
Research Site21237RosedaleMaryland
Research Site48202DetroitMichigan
Research Site64131Kansas CityMissouri
Research Site63141St LouisMissouri

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