Conditions: Breast Cancer
Keywords: luminal anastrozole fulvestrant early breast cancer HR+/HER2-
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 870
Healthy volunteers: no

Brief summary:
Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.

Detailed description:
It is expected that disease-free survival for patients receiving Anastrozole alone for 5 years will be up to 90%. An increase of 3% in disease-free survival (DFS) is expected in the arm of Fulvestrant plus Anastrozole, i.e a DFS of up to 93%. They will be required 1358 patients per treatment group (i.e, 2716 patients in total) to give 80% power, alfa bilateral 0.05, and OR 0.6888. Assuming 5% screening failures 2852 patients are required to enter the study. In Jun-2010 the recruitment was stopped due to lack of support of the financier based on the result of Faslodex® and Arimidex® in Combination Trial (FACT-trial), comparing Fulvestrant + Anastrozole vs Anastrozole alone in 1st relapse showed no difference in time to progression at more than 40 months follow-up.

Arms:
arm 1: Fulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years arm 2: Anastrozole 1 mg will be administered orally as one tablet daily for 5 years.

Interventions: intervention 1: Fulvestrant intervention 2: Anastrozole
Intervention descriptions: intervention 1: 500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years. intervention 2: 1 mg oral Anastrozole per day during 5 years.

Protocol document: