A Partially-Blind Phase III Randomized Trial of Fulvestrant (Faslodex™) With or Without Concomitant Anastrozole (Arimidex™) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-Steroidal Aromatase Inhibitors
- Compare progression-free survival of postmenopausal women with estrogen receptor-
and/or progesterone receptor-positive, locally advanced or metastatic breast cancer
that relapsed or progressed during prior treatment with nonsteroidal aromatase
inhibitors treated with fulvestrant with vs without anastrozole vs exemestane alone.
- Compare the objective complete response (CR) and partial response (PR) rate and
duration of response in patients treated with these regimens.
- Compare the clinical benefit (i.e., 6-month CR, PR, and stable disease) rate and
duration of clinical benefit in patients treated with these regimens.
- Compare time to treatment failure in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
OUTLINE: This is a randomized, partially double-blind and placebo-controlled, multicenter
study. Patients are stratified according to the setting in which prior nonsteroidal
aromatase-inhibitor therapy was given (adjuvant therapy vs first-line therapy) and
participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (fulvestrant and anastrozole): Patients receive fulvestrant intramuscularly (IM)
on days 1, 15, and 29 and then once monthly. Patients receive oral anastrozole once
- Arm II (fulvestrant and placebo): Patients receive fulvestrant as in arm I and oral
placebo once daily.
- Arm III (exemestane alone): Patients receive oral exemestane once daily. In all arms,
treatment repeats every month in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 750 patients (250 per treatment arm) will be accrued for this
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Stephen R. D. Johnston, MD, PhD, FRCP
Royal Marsden NHS Foundation Trust
United States: Federal Government