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Clinical Trial
. 2007;105 Suppl 1(Suppl 1):67-74.
doi: 10.1007/s10549-007-9702-9. Epub 2007 Oct 3.

A decade of letrozole: FACE

Joyce O'Shaughnessy  1
Affiliations
Clinical Trial

A decade of letrozole: FACE

Joyce O'Shaughnessy. Breast Cancer Res Treat. 2007.

Erratum in

  • Breast Cancer Res Treat. 2008 Nov;112(2):373

Abstract

Third-generation nonsteroidal aromatase inhibitors (AIs), letrozole and anastrozole, are superior to tamoxifen as initial therapy for early breast cancer but have not been directly compared in a head-to-head adjuvant trial. Cumulative evidence suggests that AIs are not equivalent in terms of potency of estrogen suppression and that there may be differences in clinical efficacy. Thus, with no data from head-to-head comparisons of the AIs as adjuvant therapy yet available, the question of whether there are efficacy differences between the AIs remains. To help answer this question, the Femara versus Anastrozole Clinical Evaluation (FACE) is a phase IIIb open-label, randomized, multicenter trial designed to test whether letrozole or anastrozole has superior efficacy as adjuvant treatment of postmenopausal women with hormone receptor (HR)- and lymph node-positive breast cancer. Eligible patients (target accrual, N=4,000) are randomized to receive either letrozole 2.5 mg or anastrozole 1 mg daily for up to 5 years. The primary objective is to compare disease-free survival at 5 years. Secondary end points include safety, overall survival, time to distant metastases, and time to contralateral breast cancer. The FACE trial will determine whether or not letrozole offers a greater clinical benefit to postmenopausal women with HR+ early breast cancer at increased risk of early recurrence compared with anastrozole.

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Figures

Fig. 1
Fig. 1
Changes in inhibitor-responsive genes after treatment with letrozole, anastrozole, or tamoxifen. The Venn diagrams show the numbers of genes responsive to individual inhibitors in hormone-regulated genes. Reprinted from [26], with permission from the American Association for Cancer Research
Fig. 2
Fig. 2
FACE randomized trial design
See this image and copyright information in PMC

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