A decade of letrozole: FACE

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Third-generation nonsteroidal aromatase inhibitors (AIs) like letrozole and anastrozole are effective for early breast cancer.
• Direct head-to-head adjuvant trial data comparing letrozole and anastrozole is lacking.
• Evidence suggests potential differences in estrogen suppression potency and clinical efficacy between AIs.

Purpose of the Study:

• To compare the efficacy of letrozole versus anastrozole as adjuvant therapy for postmenopausal women with hormone receptor-positive, lymph node-positive early breast cancer.
• To determine if letrozole provides superior clinical benefit compared to anastrozole in this patient population.
• To address the question of potential efficacy differences between letrozole and anastrozole in the adjuvant setting.

Main Methods:

• The Femara versus Anastrozole Clinical Evaluation (FACE) is a phase IIIb, open-label, randomized, multicenter trial.
• Approximately 4,000 eligible postmenopausal women will be randomized.
• Patients will receive either letrozole 2.5 mg or anastrozole 1 mg daily for up to 5 years.

Main Results:

• The primary objective is to compare disease-free survival at 5 years.
• Secondary endpoints include overall survival, safety, time to distant metastases, and time to contralateral breast cancer.
• The study aims to provide data on the comparative effectiveness of letrozole and anastrozole.

Conclusions:

• The FACE trial will determine if letrozole offers a greater clinical benefit than anastrozole.
• Findings will inform treatment decisions for postmenopausal women with HR+ early breast cancer at high risk of recurrence.
• This study addresses a critical gap in head-to-head comparative data for adjuvant AI therapy.