A comparative study of @entity17082 versus XXXX in post-menopausal @entity0 subjects with @entity66 .

@entity1 @entity137 @entity0 @entity66 @entity7273 @entity75 @entity17082 @entity13558 @entity2106
UNASSIGNED: 628 Background: A pilot, open-label, multicenter, multinational, randomized, parallel group, comparative study was conducted in post-menopausal @entity1 with advanced ER/ @entity7273 + @entity0 ( @entity0 ) and at least one @entity75 (liver or lung) measurable using RECIST criteria Methods: Subjects had progressed during prior antiestrogen treatment, or <=  12 months since adjuvant antiestrogen treatment. Subjects were randomized 1:1 to either @entity17082 (E) (25 mg po qd) or @entity13558 (A) (1 mg po qd). Prior treatment with <=  chemotherapy (CT) regimen for metastatic @entity0 was permitted. ECOG performance status of 0 -2. Primary efficacy end-point was objective response rate in @entity66 using modified RECIST Guidelines. Stable disease required documentation over 24 weeks. Secondary end-points included tolerability (absence of NCI CTC grade 2 -4 AEs), @entity2106 , and survival. RESULTS: The last @entity1 was enrolled 20Dec2002. 28 @entity1 remained on study drug as of 1Nov2003. Data are shown in the Table. There are no significant differences in efficacy between the two agents. Grade 3 + 4 @entity137 of interest looked similar across arms and include hot flashes in 2 (E) and 4 (A) @entity1 , musculoskeletal complaints in 2 (E) and 1 (A). CONCLUSIONS: On the basis of this study, since 40% of the @entity1 had a response or stable disease for at least 6 months, aromatase inhibitors/inactivators appear to be a suitable choice of therapy for @entity1 with visceral metastatic disease from @entity0 following antiestrogen therapy. The @entity137 profile of E and A were similar over the duration of this study treatment. [Figure: see text] [Table: see text].
