FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
The CONFIRM* Trial
Rationale for the CONFIRM trial
In a previous study of postmenopausal women with primary breast cancer treated with single doses of FASLODEX 15 to 22 days prior to surgery, increased downregulation of the estrogen receptor was shown when the dose of FASLODEX was increased.1,2 These findings, as well as the results from the initial trials of FASLODEX 250 mg showing non-inferiority to ARIMIDEX, led to the CONFIRM* trial studying a higher dose.1,2 The clinical significance of pharmacological data is unknown, and pharmacologic data do not necessarily correlate with clinical outcomes.
CONFIRM trial design
CONFIRM was a randomized, double-blind, phase III controlled study of 736 postmenopausal women (intent-to-treat population) with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.1,2
Eligible patients were randomized 1:1 to FASLODEX 500 mg or 250 mg and assessed for tumor progression every 12 weeks.2
The primary endpoint for CONFIRM was progression-free survival† (PFS).2 Overall survival (OS) was a secondary endpoint. Safety was also assessed.2