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
- Registration Number
- NCT01602380
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histological confirmation of breast cancer in post menopausal women (age >=60).<br> Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic<br> tumour tissue based on local laboratory assessment.<br><br> - EITHER locally advanced disease (1 line of chemotherapy allowed only if remain<br> unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of<br> chemotherapy for breast cancer allowed only if subsequent evidence of further<br> progressive disease)<br><br> - At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed<br> at baseline and is suitable for repeated assessment.<br><br> - Postmenopausal women, fulfilling 1 of:<br><br> - Prior bilateral oophorectomy<br><br> - Age >60 years<br><br> - Age < 60 years and amenorrheic for 12+months in the absence of chemotherapy,<br> tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the<br> postmenopausal range<br><br>Exclusion Criteria:<br><br> - Presence of life-threatening metastatic disease<br><br> - Any of:<br><br> - Extensive hepatic involvement<br><br> - involving brain or meninges<br><br> - symptomatic pulmonary lymph spread<br><br> - Discrete lung metastases are acceptable if respiratory function is not significantly<br> compromised<br><br> - Prior systemic therapy for breast cancer other than one line of cytotoxic<br> chemotherapy (the last dose of chemotherapy must have been received more than 28<br> days prior to randomisation)<br><br> - Radiation therapy if not completed within 28 days prior to randomisation (with the<br> exception of radiotherapy given for control of bone pain, started prior to<br> randomisation). Prior hormonal treatment for breast cancer.<br><br> - Current or prior malignancy within previous 3 years (other than breast cancer or<br> adequately treated basal cell or squamous cell carcinoma of the skin or in situ<br> carcinoma of the cervix).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
- Secondary Outcome Measures
Name Time Method Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events;Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment;Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment;Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment;Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment;Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment;Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment;Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)