RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen. PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.
OBJECTIVES: * Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer. * Determine the safety profile of exemestane in these patients. * Compare the overall survival of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only). Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 18 months and then at least every 6 months thereafter. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
342
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Bankstown - Lidcombe Hospital
Bankstown, Australia
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium
Institut Jules Bordet
Brussels (Bruxelles), Belgium
Centre Hospitalier Etterbeek Ixelles
Brussels (Bruxelles), Belgium
Hopital de Jolimont
Haine-Saint-Paul, Belgium
Centre Hospitalier Universitaire de Tivoli
La Louvière, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
...and 38 more locations