CONFIRM Study Design
FASLODEX 500 mg vs 250 mg
The CONFIRM study was a randomized, double-blind, controlled study.1,2
The study participants consisted of 736 postmenopausal women (ITT* population) with metastatic breast cancer relapsing or progressing after prior endocrine therapy.
*Intent-to-treat population.
Patients received the same number of injections
- FASLODEX 500-mg arm received 2 x 250-mg injections on days 1, 15, and 29 and once monthly thereafter
- FASLODEX 250-mg arm received 1 x 250-mg injection plus one placebo injection on days 1, 15 (2 placebo injections only), and 29 and once monthly thereafter
Disease Burden at Randomization3†
†These numbers do not add up to 100%, since some patients had multiple sites involved.
Progression/Recurrence History at Randomization3
- Most patients had recurrence during or within 12 months of completing adjuvant hormonal therapy (52.6%) or had progressed on their first endocrine treatment for de novo advanced disease (34.6%)
Preplanned for study of the following subgroups2,4
- Receptor status
- Visceral involvement
- Response to last hormonal therapy before FASLODEX
- Measurable disease
- Age
View the data for efficacy
FASLODEX is indicated for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease
progression following antiestrogen therapy.
IMPORTANT SAFETY INFORMATION:
FASLODEX is contraindicated in patients with known hypersensitivity to the drug or to
any of its components. Hypersensitivity reactions, including urticaria and angioedema have been reported in association with FASLODEX.
Click Here for Additional Safety Information
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