Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer (FACE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Letrozole; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00248170

2005-004263-35 (EudraCT Number)

CFEM345D2411

EUDRACT number 2005-004263-35 (Registry Identifier)

Details and patient eligibility

About

Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Enrollment: 4,172 patients

Sex: Female

Ages: 33 to 96 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recent primary surgery for breast cancer
• Early stage breast cancer
• Postmenopausal
• Hormone receptor positive
• Positive lymph node involvement

Exclusion criteria

• Metastatic disease
• Presence of contralateral breast cancer including DCIS
• Progression

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4,172 participants in 2 patient groups

Letrozole

Experimental group

Description:

2.5 mg by mouth (p.o.) once daily

Treatment:

Drug: Letrozole

Anastrozole

Active Comparator group

Description:

1 mg p.o. once daily

Treatment:

Drug: Anastrozole