A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00065325Tipo: INTERVENTIONALInicio: 1 de ago de 2003Fin estimado: 1 de sept de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Elegibilidad

Edad mínima: 32 YearsEdad máxima: 91 YearsSexo: FEMALE

Criterios de inclusión

Biopsy confirmation of Breast Cancer
Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
Postmenopausal women defined as a women who has stopped having menstrual periods
Evidence of hormone sensitivity
Written informed consent to participate in the trial

Criterios de exclusión

Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
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 or Exemestane (i.e. castor oil or Mannitol)

Intervenciones

drug

Fulvestrant

intramuscular injection

drug

Exemestane

oral capsule

Ubicaciones

Research Site

Buenos Aires, Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

Research Site

Mar del Plata, Buenos Aires, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalAstraZeneca

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