A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

CompletadoFase 3ClinicalTrials.gov

ID: NCT01602380Tipo: INTERVENTIONALInicio: 17 de oct de 2012Fin estimado: 16 de ene de 2026

Oncología Endocrinología Obstetricia y Ginecología

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

Descripción detallada

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg with Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: FEMALE

Criterios de inclusión

Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment.
EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease)
At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment.
Postmenopausal women, fulfilling 1 of:
Prior bilateral oophorectomy
Age \>60 years
Age \< 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range

Criterios de exclusión

Presence of life-threatening metastatic disease
Any of:
Extensive hepatic involvement
involving brain or meninges
symptomatic pulmonary lymph spread
Discrete lung metastases are acceptable if respiratory function is not significantly compromised
Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation)
Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer.
Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

Intervenciones

drug

faslodex 500mg

2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

drug

arimidex 1mg

oral tablet 1 daily

drug

faslodex dummy

2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter

drug

arimidex dummy

oral tablet 1 daily

Ubicaciones

Research Site

La Rioja, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Pergamino, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

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