To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
298
take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
Time to Progression (TTP) - Expert Evaluation Committee Assessment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Time frame: Up to 2008 days of the treatment
Time to Progression (TTP) - Investigators Assessment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Time frame: Up to 2008 days of the treatment
Number of Participants With Objective Response - Investigators Assessment
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.
Time frame: Up to 2008 days of the treatment
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Pfizer Investigational Site
Toyohashi, Aiche, Japan
Pfizer Investigational Site
Anjo, Aichi-ken, Japan
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Toyoake, Aichi-ken, Japan
Pfizer Investigational Site
Toyota, Aichi-ken, Japan
Pfizer Investigational Site
Chiba, Chiba, Japan
Pfizer Investigational Site
Sakura, Chiba, Japan
Pfizer Investigational Site
Matsuyama, Ehime, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
...and 37 more locations
Number of Participants With Clinical Benefit - Investigator Assessment
Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD
Time frame: Up to 2008 days of the treatment
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death.
Time frame: Up to 2008 days of the treatment
Time to Treatment Failure (TTF)
TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.
Time frame: Up to 2008 days of the treatment