Fulvestrant With or Without Anastrozole or Exemestane Alone in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer.
PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival [ Designated as safety issue: No ]
- Objective complete response (CR) and partial response (PR) rate [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Designated as safety issue: No ]
- Duration of clinical benefit [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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 daily.
- 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 toxicity.
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 study.
|Royal Marsden - London|
|London, England, United Kingdom, SW3 6JJ|
|Institute of Cancer Research - Sutton|
|Sutton, England, United Kingdom, SM2 5NG|
|Study Chair:||Stephen R. D. Johnston, MD, PhD, FRCP||Royal Marsden NHS Foundation Trust|