The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
482
Progression Free Survival as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time from the date of randomization until the date of objective disease progression (as per RECIST 1.1) or the date of death (by any cause in the absence of progression). Disease progression is defined using RECIST 1.1 as \>=20% increase in the sum of longest diameters of target lesions and an absolute increase of \>=5mm, taking as reference the smallest sum of longest diameters of target lesions since study start, or unequivocal progression in non-target lesions, or appearance of any new lesions.
Time frame: Tumour assessment by RECIST 1.1 every 12 weeks until data cut-off at 31 August 2012
Compare the Overall Survival in Patients Treated With AZD8931 in Combination With Anastrozole Versus Anastrozole Alone
Time from the date of randomization to the date of death (by any cause)
Time frame: Following progression, patients were contacted at 12 weekly intervals until data cut-off at 31 August 2012 to determine survival status
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Lake Success, New York, United States
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Belo Horizonte, Brazil
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Goiânia, Brazil
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Ijuí, Brazil
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Porto Alegre, Brazil
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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