A global study to compare the effects of fulvestrant and arimidex in a subset of patients with breast cancer

• Conditions: hormone receptor positive breast cancer, hormone naive, breast cancer, neoplasm breast cancer, metastatic, tumour neoplasm; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006326-24-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-28
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1 Histological confirmation of breast cancer in post menopausal women
(age >=60)
2 Positive hormone receptor status (ER +ve and/or PgR +ve) of primary
or metastatic tumour tissue based on local laboratory assessment.
3 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)
4 At least 1 lesion (measurable and/or non-measurable) that can be
accurately assessed at baseline and is suitable for repeated assessment.
5 Postmenopausal woman, 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

1 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
2 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).
3 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).
4 Prior hormonal treatment for breast cancer.
5 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified