Fulvestrant can therefore be considered as alternative therapy to anastrozole or exemestane in postmenopausal women with locally advanced or metastatic breast cancer that has recurred on prior adjuvant endocrine therapy or progressed on prior endocrine therapy for advanced disease .
A systematic review was undertaken to examine all available evidence to develop and support clinical recommendations regarding the use of fulvestrant ( Faslodex ® ) as systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women .
Randomized clinical trial design for assessing noninferiority when superiority is expected.
The r and omized clinical trial ( RCT ) is the gold st and ard for definitive evaluation of new therapies . RCTs design ed to show that the therapeutic efficacy of a new therapy is not unacceptably inferior to that of st and ard therapy are called noninferiority trials . Traditionally , noninferiority trials have required very large sample sizes . Sometimes , a new treatment regimen with a favorable toxicity and /or tolerability profile is also expected to have some modest improvement in efficacy . In such specialized setting s we describe a hybrid trial- design approach that requires a dramatically smaller sample size than that of a st and ard noninferiority design . This hybrid design can naturally incorporate a formal test of superiority as well as noninferiority
Fulvestrant can therefore be considered as alternative therapy to anastrozole or exemestane in postmenopausal women with locally advanced or metastatic breast cancer that has recurred on prior adjuvant endocrine therapy or progressed on prior endocrine therapy for advanced disease .
A systematic review was undertaken to examine all available evidence to develop and support clinical recommendations regarding the use of fulvestrant ( Faslodex ® ) as systemic therapy of locally advanced or metastatic breast cancer in postmenopausal women .