Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Drugs used in chemotherapy such as CCI-779 use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether letrozole is more effective with or without CCI-779 in treating patients with breast cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of letrozole with or without CCI-779 in treating postmenopausal women who have locally advanced or metastatic breast cancer.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Randomized, Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral CCI-779, Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer|
|Study Start Date:||March 2003|
- Compare the objective response rate of postmenopausal women with locally advanced or metastatic breast cancer treated with letrozole with vs without CCI-779.
- Compare the overall response rate, including stable disease lasting at least 6 months, time to progression, and time to treatment failure, in patients treated with these regimens.
- Compare the pharmacokinetics of these regimens in these patients.
- Compare the safety of these regimens in these patients.
- Correlate the pharmacodynamics of these regimens with clinical response in these patients.
- Compare the impact of these regimens on patient-reported health outcomes.
- Compare progression-free rates at various intervals in patients treated with these regimens.
- Compare duration of response and overall survival of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral letrozole and oral CCI-779 daily.
- Arm II: Patients receive oral letrozole on days 1-14 and oral CCI-779 on days 1-5. Courses repeat every 14 days.
- Arm III: Patients receive oral letrozole daily on days 1-5. Courses repeat every 14 days. Patients with disease progression may cross over to oral CCI-779 alone on days 1-5 every 14 days.
In all arms, treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 108 patients (36 per treatment arm) will be accrued for this study.
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106-5055|
|Study Chair:||Beth A. Overmoyer, MD, FACP||Case Comprehensive Cancer Center|