Ensayo fase II aleatorizado, abierto, de grupos paralelos, multicéntrico para comparar la eficacia y tolerabilidad de fulvestrant (FASLODEX®) 500 mg con anastrozol (ARIMIDEX®) 1 mg en el tratamiento hormonal de primera línea de mujeres posmenopáusicas con cáncer de mama avanzado y receptores hormonales positivos. - FIRST

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

1.Provision of written informed consent
2.Histological/cytological confirmation of breast cancer
3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters
4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent:
(a)who have never had hormonal therapy for locoregionally advanced or metastatic disease
and
(b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation.
5.Patients fulfilling one of the following criteria:
·Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan
·Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible
6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
·Age = 60 years
·Age = 45 years with amenorrhoea = 12 months with an intact uterus
·Having undergone a bilateral oophorectomy
·FSH and oestradiol levels in postmenopausal range (utilising ranges from the local laboratory facility)*
* In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomisation and menses must not have restarted.
7.WHO performance status 0, 1 or 2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
1.Provision of written informed consent
2.Histological/cytological confirmation of breast cancer
3.Documented positive hormone receptor status (ER +ve and/or PgR + ve) of primary or metastatic tumour tissue, according to the local laboratory parameters
4.Patients with metastatic or locally advanced disease not amenable to therapy with curative intent:
(a)who have never had hormonal therapy for locoregionally advanced or metastatic disease
and
(b)For patients who have received previous adjuvant or neoadjuvant hormonal treatment, this must have been completed more than 12 months prior to randomisation.
5.Patients fulfilling one of the following criteria:
·Patients with measurable disease as per RECIST criteria. This is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with spiral CT scan
·Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. Bone lesions must be evaluable by plain X-ray, CT or MRI. Patients with lesions identified only on radionucleotide bone scan are not eligible
6. Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria:
·Age = 60 years
·Age = 45 years with amenorrhoea = 12 months with an intact uterus
·Having undergone a bilateral oophorectomy
·FSH and oestradiol levels in postmenopausal range (utilising ranges from the local laboratory facility)*
* In patients who have previously been treated with an LH-RH analogue, the last depot must have been administered more than 4 months prior to randomisation and menses must not have restarted.
7.WHO performance status 0, 1 or 2.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease
2.Previous systemic therapy for advanced breast cancer.
3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation
4.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)
5.Any of the following laboratory values within 3 weeks of randomisation:
·Platelets < 100 x 10 to the power of 9 / L
·Total bilirubin > 1.5 x ULRR**
** Patients with confirmed Gilbert’s syndrome may be included in the study
·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases
6.History of :
·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil
8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.

;
1.Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease
2.Previous systemic therapy for advanced breast cancer.
3.Treatment with a non-approved or experimental drug within 4 weeks before randomisation
4.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)
5.Any of the following laboratory values within 3 weeks of randomisation:
·Platelets < 100 x 10 to the power of 9 / L
·Total bilirubin > 1.5 x ULRR**
** Patients with confirmed Gilbert’s syndrome may be included in the study
·ALT or AST > 2.5 x ULRR if no demonstrable liver metastases or > 5 x ULRR in presence of liver metastases
6.History of :
·bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
·long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
7.History of hypersensitivity to active or inactive excipients of fulvestrant, aromatase inhibitors or castor oil
8.Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus.