Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study

Patrocinadores

Patrocinador principal: Federal University of São Paulo

Fuente Federal University of São Paulo
Resumen breve

Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.

Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).

Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.

Estado general Completed
Fecha de inicio April 2005
Fecha de Terminación June 2008
Fecha de finalización primaria July 2007
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Expression of progesterone end of the study (june 2008)
Resultado secundario
Medida Periodo de tiempo
Expression of Ki-67 end of the study (june 2008)
Inscripción 71
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Anastrozole

Descripción: Tamoxifen 20mg and anastrozole 1 mg

Elegibilidad

Criterios:

Inclusion Criteria:

- Invasive breast cancer post-menopausal women

- Estrogen and/or progesterone receptor positive

Exclusion Criteria:

- Patients with endocrine disease

- Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis

- Patients with a negative expression for estrogen and/or progesterone receptors

- Women with a history of thromboembolism

- Patients who had previously undergone any treatment for breast cancer

Género: Female

Edad mínima: 40 Years

Edad máxima: 90 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel
Andre Mattar, MD Principal Investigator
Ubicación
Instalaciones: Sao Paulo Federal University
Ubicacion Paises

Brazil

Fecha de verificación

November 2009

Fiesta responsable

Nombre Titulo: Andre Mattar MD

Organización: Federal University of Sao Paulo

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Placebo

Etiqueta: Tamoxifen

Tipo: Other

Descripción: Tamoxifen 20 mg day 26 days

Etiqueta: Anastrozole

Tipo: Other

Descripción: Anastrozole 1mg 26 days

Información de diseño del estudio

Asignación: Randomized

Propósito primario: Basic Science

Enmascaramiento: Double

Fuente: ClinicalTrials.gov