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Brief Title: Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients
Official Title: Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer
Study ID: NCT00128843
Brief Summary: This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.
Detailed Description: The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Germans Trias i Pujol, Badalona, Barcelona, Spain
Clínico Universitario A Coruña (CHUAC), A Coruña, Galicia, Spain
Onkologikoa, Donostia-San Sebastián, Guipúzcoa, Spain
Hospital Donostia, Donostia-San Sebastián, Guipúzcoa, Spain
H Comarcal de Barbastro, Barbastro, Huesca, Spain
H Puerto de Sagunto, Sagunto, Valencia, Spain
Hospital Clínico Universitario San Carlos, Madrid, , Spain
Puerta de Hierro, Madrid, , Spain
Ruber Internacional, Madrid, , Spain
H Sant Camil, Tarragona, , Spain
Instituto Valenciano de Oncología (IVO), Valencia, , Spain
Clínico Lozano Blesa, Zaragoza, , Spain
H Universitario Miguel Servet, Zaragoza, , Spain
Name: Study Director
Affiliation: Instituto Valenciano de Oncología
Role: STUDY_DIRECTOR