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

Phase 1

• 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-CZ
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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:
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

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate superior progression free survival for patients treated with fulvestrant 500mg versus patients treated with anastrozole 1mg;Secondary Objective: To compare the overall survival, objective responses, clinical benefit responses, quality of life and safety profile for study patients ;Primary end point(s): Compare the progression free survival (PFS) in patients treated with fulvestrant with those treated with anastrozole ;Timepoint(s) of evaluation of this end point: Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease.