Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer.
Drug: tamoxifen citrate
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer|
- Relapse-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Incidence of second breast cancer in contralateral breast [ Designated as safety issue: No ]
- Safety and long term tolerability [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
|Study Completion Date:||April 2009|
- Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer.
- Compare the relapse-free survival and overall survival of patients treated with these drugs.
- Compare the incidence of contralateral breast cancer in patients treated with these drugs.
- Compare the safety and long-term tolerability of these drugs in these patients.
- Compare the quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or more nodes positive). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily
- Arm II: Patients receive oral exemestane once daily. Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and at months 3 and 12 during study.
Patients are followed at least annually.
PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued for this study.
|City Hospital - Birmingham|
|Birmingham, England, United Kingdom, B18 7QH|
|Study Chair:||Daniel Rea, MD||City Hospital - Birmingham|