The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
State Medical Institution
Pyatigorsk, Stavropol Kray, Russia
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
Chelyabinsk, Russia
The primary efficacy endpoint is overall response rate (ORR)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Progression-free survival (PFS)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Time to progression (TTP)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Duration of overall response and duration of stable disease
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Clinical benefit rate (CBR)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Safety and tolerability of AS1402 when combined with letrozole
Time frame: Radiological evaluations are performed every 12 weeks up to progression
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