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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.
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.

NCT00099437

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: Fulvestrant

Countries: United States, Belgium, Brazil, Chile, Colombia, Czechia, Hungary, India

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 overview

Sex: FEMALE

Age: 45 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (106)
  • Casa Grande, Arizona, United States
  • Fountain Valley, California, United States
  • New Britain, Connecticut, United States
  • Crystal River, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Urbana, Illinois, United States
  • Rosedale, Maryland, United States
  • Detroit, Michigan, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Voorhees Township, New Jersey, United States
  • Greenville, North Carolina, United States
  • Pasadena, Texas, United States
  • West Bend, Wisconsin, United States
  • Brasschaat, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Edegem, Belgium
  • Ghent, Belgium
  • Hasselt, Belgium
  • Liège, Belgium
  • Turnhout, Belgium
  • Barretos, Brazil
  • Londrina, Brazil
  • Porto Alegre, Brazil
  • Recife, Brazil
  • Salvador, Brazil
  • São Paulo, Brazil
  • Antofagasta, Chile
  • Santiago, Chile
  • + 76 more on CT.gov